Healthy SubjectsPhase 1NCT03436849
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects
A Phase 1 study testing ESN364 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ESN364
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- 22 Feb 2018to 23 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subject between 20 to < 45 years of age, or female subject between 20 to < 65 years of age.
- Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
- Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].
Who cannot join
- Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
- Subject has had previous exposure with ESN364.
- Subject has any clinically significant history of allergic conditions prior to study drug administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
- Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
- Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission.
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- Subjects who has any significantly abnormal results of laboratory tests at screening or on the day of hospital admission.
- Subjects who are positive for any of urinary drug abuse test or serology test at screening.
- Subject took a drug or underwent therapy within 2 weeks prior to hospital admission.
- Subjects used a drug or underwent therapy that affects sex hormones within 3 months prior to hospital admission.
- Subjects who had bilateral orchiectomy.
- Subject has used any inducer of metabolism in the 3 months prior to hospital admission.
- Subject has a history of smoking more than 10 cigarettes per day within 3 months prior to screening test.
- Subject consumes, on average, more than approximately 500 mg/day of caffeine
- Subject has a history of consuming more than 30 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening.
- Subjects who conducted or is scheduled to conduct any blood donation or blood drawing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of ESN364 - Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Japanese Male and Healthy Japanese Pre- and Postmenopausal Female Subjects -
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.
Read the detailed description
This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).
- Conditions
- Healthy Subjects
- Being tested
- ESN364, Placebo
- Keywords
- ASP2693, Pharmacodynamics, Pharmacokinetics, ESN364, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESN364Drug
ESN364 will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| ESN364 dose-1 group in Part 1 | Experimental | Healthy male subjects will receive a single dose of ESN364. Receives: Drug: ESN364 |
| ESN364 dose-2 group in Part 1 | Experimental | Healthy male subjects will receive a single dose of ESN364. Receives: Drug: ESN364 |
| Placebo group in Part 1 | Placebo comparator | Healthy male subjects will receive a single dose of Placebo. Receives: Drug: Placebo |
| Male ESN364 group in Part 2 | Experimental | Healthy male subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level. Receives: Drug: ESN364 |
| Pre-menopausal female ESN364 group in Part 2 | Experimental | Healthy pre-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level. Receives: Drug: ESN364 |
| Post-menopausal female ESN364 group in Part 2 | Experimental | Healthy post-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level. Receives: Drug: ESN364 |
| Male placebo group in Part 2 | Placebo comparator | Healthy male subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days. Receives: Drug: Placebo |
| Pre-menopausal female placebo group in Part 2 | Placebo comparator | Healthy pre-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days. Receives: Drug: Placebo |
| Post-menopausal female placebo group in Part 2 | Placebo comparator | Healthy post-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence of adverse events (AEs) in Part 1
AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to Day 12 in Part 1
Safety assessed by incidence of AEs in Part 2
AEs will be coded using MedDRA.
Measured: Up to Day 24 in Part 2
Safety assessed by vital signs: Body temperature in Part 1
To assess vital signs as a criterion of safety variables.
Measured: Up to day 12 in Part 1
Safety assessed by vital signs: Body temperature in Part 2
To assess vital signs as a criterion of safety variables.
Measured: Up to Day 24 in Part 2
Safety assessed by vital signs: Blood pressure in Part 1
To assess vital signs as a criterion of safety variables.
Measured: Up to Day 12 in Part 1
Safety assessed by vital signs: Blood pressure in Part 2
To assess vital signs as a criterion of safety variables.
Measured: Up to Day 24 in Part 2
Safety assessed by vital signs: Pulse rate in Part 1
To assess vital signs as a criterion of safety variables.
Measured: Up to Day 12 in Part 1
Safety assessed by vital signs: Pulse rate in Part 2
To assess vital signs as a criterion of safety variables.
Measured: Up to Day 24 in Part 2
Safety assessed by laboratory test: Hematology in Part 1
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to Day 12 in Part 1
Safety assessed by laboratory test: Hematology in Part 2
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to Day 24 in Part 2
Safety assessed by laboratory test: Biochemistry in Part 1
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to Day 12 in Part 1
Safety assessed by laboratory test: Biochemistry in Part 2
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to Day 24 in Part 2
Safety assessed by laboratory test: Urinalysis in Part 1
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to Day 12 in Part 1
Safety assessed by laboratory test: Urinalysis in Part 2
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to Day 24 in Part 2
Safety assessed by standard 12-lead electrocardiogram (ECG) in Part 1
Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.
Measured: Up to Day 12 in Part 1
Safety assessed by standard ECG in Part 2
Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.
Measured: Up to Day 24 in Part 2
Safety assessed by ECG parameters: Heart rate in Part 1
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: Heart rate in Part 2
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing on Day 10 in multiple dose (MD) of Part 2
Safety assessed by ECG parameters: QT interval in Part 1
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: QT interval in Part 2
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: RR interval in Part 1
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: RR interval in Part 2
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: PR interval in Part 1
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: PR interval in Part 2
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: QRS interval in Part 1
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: QRS interval in Part 2
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by ECG parameters: QTc interval corrected by Fridericia method (QTcF) in Part 1
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing in Part 1
Safety assessed by ECG parameters: QTcF in Part 2
To assess ECG parameters as a criterion of safety variables.
Measured: Up to 24 hr after dosing on Day 10 in MD of Part 2
Safety assessed by body weight in Part 1
To assess body weight as a criterion of safety variables
Measured: Up to Day 3 in Part 1
Safety assessed by body weight in Part 2
To assess body weight as a criterion of safety variables
Measured: Up to Day 15 in Part 2
Safety assessed by menstrual cycle in pre-menopausal females
To assess menstrual cycle as a criterion of safety variables
Measured: Up to an average of two weeks after last dosing
Secondary outcomes (71)
Pharmacokinetics (PK) parameter for ESN364 and its metabolite: Area under the concentration-time curve (AUC) from the time of dosing to time 24 h (AUC24) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2
PK parameter for ESN364 and its metabolite: AUC from the time of dosing extrapolated to time infinity (AUCinf) in plasma
To assess the PK of ESN364 and its metabolite4 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2
PK parameter for ESN364 and its metabolite: Percentage of AUCinf (AUCinf(%extrap)) in plasma
To assess the PK of ESN364 and its metabolite in Part 1.
Measured: Up to 48 hr after dosing in Part 1
PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the last measurable concentration (AUClast) in plasma
To assess the PK of ESN364 and its metabolite in Part 1.
Measured: Up to 48 hr after dosing in Part 1
PK parameter for ESN364 and its metabolite: Maximum concentration (Cmax) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Apparent total clearance after extra-vascular dosing (CL/F) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Time of the maximum concentration： (tmax) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Terminal elimination half-life (t1/2) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) in plasma
To assess the PK of ESN364 and its metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 metabolite: Metabolite to parent ratio (MPR) in plasma
To assess the PK of ESN364 metabolite in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the start of the next dosing interval (AUCtau) in plasma
To assess the PK of ESN364 and its metabolite in Part 2.
Measured: Up to 48 hr after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Peak-trough ratio (PTR) in plasma
To assess the PK of ESN364 and its metabolite in Part 2.
Measured: Up to 48 hr after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Accumulation ratio calculated using AUC (Rac(AUC)) in plasma
To assess the PK of ESN364 and its metabolite in Part 2.
Measured: Up to 48 hr after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Concentration immediately prior to dosing at multiple dosing (Ctrough) in plasma
To assess the PK of ESN364 and its metabolite in Part 2.
Measured: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
Pharmacodynamic (PD) endpoint for ESN364: Luteinizing hormone (LH) level in plasma
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for LH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for LH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for LH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for LH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for LH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) for LH level
To assess the PD of ESN364 in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for LH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Follicle stimulating hormone (FSH) level in plasma
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for FSH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for FSH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for FSH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for FSH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for FSH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for FSH level
To assess the PD of ESN364 in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for FSH level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Sex hormone binding globulin (SHBG) level in plasma
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for SHBG level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for SHBG level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for SHBG level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for SHBG level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for SHBG level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for SHBG level
To assess the PD of ESN364 in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for SHBG level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Total testosterone (TT) level in plasma
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC24 for TT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC12 for TT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for TT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for TT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for TT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for TT level
To assess the PD of ESN364 in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for TT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Free testosterone (FT) level in plasma
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for FT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for FT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for FT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for FT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for FT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for FT level
To assess the PD of ESN364 in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for FT level
To assess the PD of ESN364 in Part 1 and Part 2.
Measured: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Estradiol (E) level in plasma
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2.
PD endpoint for ESN364: Cmin for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for E level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Progesterone (P) level in plasma
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2.
PD endpoint for ESN364: Cmin for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Up to 48 hr after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for P level
To assess the PD of ESN364 in female subjects in Part 2.
Measured: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start22 Feb 2018
- Primary completion23 May 2018
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436849
- Sponsor's protocol ID
- 2693-CL-0020
- Status last verified
- Apr 2019
- First submitted
- 30 Jan 2018
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of ESN364 - Placebo-controlled, Single and Multiple Oral Dose Study in Healthy Japanese Male and Healthy Japanese Pre- and Postmenopausal Female Subjects -
- ClinicalTrials.gov ID
- NCT03436849
- Acronym / sponsor ID
- 2693-CL-0020
- Conditions
- Healthy Subjects
- Keywords
- ASP2693, Pharmacodynamics, Pharmacokinetics, ESN364, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral doses of ESN364 in healthy Japanese male and pre- and post-menopausal female subjects. This study will also evaluate the pharmacokinetics (PK) of ESN364 and its metabolite, and the pharmacodynamics (PD) of ESN364 after single and multiple oral doses administration in healthy Japanese male and pre- and post-menopausal female subjects.
Detailed description
This study consists of two parts. Part 1; Single Dose (SD) and Part 2; Single and Multiple Dose (SD and MD).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| ESN364 dose-1 group in Part 1 | Experimental | Drug: ESN364Healthy male subjects will receive a single dose of ESN364. |
| ESN364 dose-2 group in Part 1 | Experimental | Drug: ESN364Healthy male subjects will receive a single dose of ESN364. |
| Placebo group in Part 1 | Placebo comparator | Drug: PlaceboHealthy male subjects will receive a single dose of Placebo. |
| Male ESN364 group in Part 2 | Experimental | Drug: ESN364Healthy male subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level. |
| Pre-menopausal female ESN364 group in Part 2 | Experimental | Drug: ESN364Healthy pre-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level. |
| Post-menopausal female ESN364 group in Part 2 | Experimental | Drug: ESN364Healthy post-menopausal female subjects will receive a single dose of ESN364 followed by washout period, then receive once daily dosing of ESN364 for 10 consecutive days at the same dose level. |
| Male placebo group in Part 2 | Placebo comparator | Drug: PlaceboHealthy male subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days. |
| Pre-menopausal female placebo group in Part 2 | Placebo comparator | Drug: PlaceboHealthy pre-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days. |
| Post-menopausal female placebo group in Part 2 | Placebo comparator | Drug: PlaceboHealthy post-menopausal female subjects will receive a single dose of Placebo followed by washout period, then receive once daily dosing of Placebo for 10 consecutive days. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subject between 20 to < 45 years of age, or female subject between 20 to < 65 years of age.
- Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
- Body mass index (BMI) at screening: range of ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].
Key exclusion criteria (16 listed)
- Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 84 days prior to screening.
- Subject has had previous exposure with ESN364.
- Subject has any clinically significant history of allergic conditions prior to study drug administration.
- Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy.
- Subject has contracted pyretic or symptomatic viral, bacterial, or fungal infection within 7 days prior to hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESN364ESN364 will be administered orally. | Drug | ESN364 dose-1 group in Part 1, ESN364 dose-2 group in Part 1, Male ESN364 group in Part 2, Post-menopausal female ESN364 group in Part 2, Pre-menopausal female ESN364 group in Part 2 |
| PlaceboPlacebo will be administered orally. | Drug | Male placebo group in Part 2, Placebo group in Part 1, Post-menopausal female placebo group in Part 2, Pre-menopausal female placebo group in Part 2 |
Primary outcome
Safety assessed by incidence of adverse events (AEs) in Part 1
Time frame: Up to Day 12 in Part 1
AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Safety assessed by incidence of AEs in Part 2
Time frame: Up to Day 24 in Part 2
AEs will be coded using MedDRA.
Safety assessed by vital signs: Body temperature in Part 1
Time frame: Up to day 12 in Part 1
To assess vital signs as a criterion of safety variables.
Safety assessed by vital signs: Body temperature in Part 2
Time frame: Up to Day 24 in Part 2
To assess vital signs as a criterion of safety variables.
Safety assessed by vital signs: Blood pressure in Part 1
Time frame: Up to Day 12 in Part 1
To assess vital signs as a criterion of safety variables.
Safety assessed by vital signs: Blood pressure in Part 2
Time frame: Up to Day 24 in Part 2
To assess vital signs as a criterion of safety variables.
Safety assessed by vital signs: Pulse rate in Part 1
Time frame: Up to Day 12 in Part 1
To assess vital signs as a criterion of safety variables.
Safety assessed by vital signs: Pulse rate in Part 2
Time frame: Up to Day 24 in Part 2
To assess vital signs as a criterion of safety variables.
Safety assessed by laboratory test: Hematology in Part 1
Time frame: Up to Day 12 in Part 1
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Safety assessed by laboratory test: Hematology in Part 2
Time frame: Up to Day 24 in Part 2
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Safety assessed by laboratory test: Biochemistry in Part 1
Time frame: Up to Day 12 in Part 1
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Safety assessed by laboratory test: Biochemistry in Part 2
Time frame: Up to Day 24 in Part 2
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Safety assessed by laboratory test: Urinalysis in Part 1
Time frame: Up to Day 12 in Part 1
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Safety assessed by laboratory test: Urinalysis in Part 2
Time frame: Up to Day 24 in Part 2
To assess laboratory values as a criterion of safety variables. Potentially clinically significant laboratory values will be reported as AEs.
Safety assessed by standard 12-lead electrocardiogram (ECG) in Part 1
Time frame: Up to Day 12 in Part 1
Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.
Safety assessed by standard ECG in Part 2
Time frame: Up to Day 24 in Part 2
Subjects should keep rest for 5 minutes before evaluation. Any clinically significant adverse changes on the ECG will be reported as AEs.
Safety assessed by ECG parameters: Heart rate in Part 1
Time frame: Up to 24 hr after dosing in Part 1
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: Heart rate in Part 2
Time frame: Up to 24 hr after dosing on Day 10 in multiple dose (MD) of Part 2
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: QT interval in Part 1
Time frame: Up to 24 hr after dosing in Part 1
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: QT interval in Part 2
Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: RR interval in Part 1
Time frame: Up to 24 hr after dosing in Part 1
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: RR interval in Part 2
Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: PR interval in Part 1
Time frame: Up to 24 hr after dosing in Part 1
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: PR interval in Part 2
Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: QRS interval in Part 1
Time frame: Up to 24 hr after dosing in Part 1
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: QRS interval in Part 2
Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: QTc interval corrected by Fridericia method (QTcF) in Part 1
Time frame: Up to 24 hr after dosing in Part 1
To assess ECG parameters as a criterion of safety variables.
Safety assessed by ECG parameters: QTcF in Part 2
Time frame: Up to 24 hr after dosing on Day 10 in MD of Part 2
To assess ECG parameters as a criterion of safety variables.
Safety assessed by body weight in Part 1
Time frame: Up to Day 3 in Part 1
To assess body weight as a criterion of safety variables
Safety assessed by body weight in Part 2
Time frame: Up to Day 15 in Part 2
To assess body weight as a criterion of safety variables
Safety assessed by menstrual cycle in pre-menopausal females
Time frame: Up to an average of two weeks after last dosing
To assess menstrual cycle as a criterion of safety variables
71 secondary outcomes
Pharmacokinetics (PK) parameter for ESN364 and its metabolite: Area under the concentration-time curve (AUC) from the time of dosing to time 24 h (AUC24) in plasma
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2
PK parameter for ESN364 and its metabolite: AUC from the time of dosing extrapolated to time infinity (AUCinf) in plasma
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2
PK parameter for ESN364 and its metabolite: Percentage of AUCinf (AUCinf(%extrap)) in plasma
Time frame: Up to 48 hr after dosing in Part 1
PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the last measurable concentration (AUClast) in plasma
Time frame: Up to 48 hr after dosing in Part 1
PK parameter for ESN364 and its metabolite: Maximum concentration (Cmax) in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Apparent total clearance after extra-vascular dosing (CL/F) in plasma
Time frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag) in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Time of the maximum concentration： (tmax) in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Terminal elimination half-life (t1/2) in plasma
Time frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: volume of distribution during the terminal elimination phase after extra-vascular dosing (Vz/F) in plasma
Time frame: Up to 48 hr after dosing in Part 1 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 metabolite: Metabolite to parent ratio (MPR) in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: AUC from the time of dosing to the start of the next dosing interval (AUCtau) in plasma
Time frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Peak-trough ratio (PTR) in plasma
Time frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Accumulation ratio calculated using AUC (Rac(AUC)) in plasma
Time frame: Up to 48 hr after dosing on Day 10 in MD part of Part 2
PK parameter for ESN364 and its metabolite: Concentration immediately prior to dosing at multiple dosing (Ctrough) in plasma
Time frame: Before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
Pharmacodynamic (PD) endpoint for ESN364: Luteinizing hormone (LH) level in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for LH level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for LH level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for LH level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for LH level
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for LH level
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) for LH level
Time frame: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for LH level
Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Follicle stimulating hormone (FSH) level in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for FSH level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for FSH level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for FSH level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for FSH level
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for FSH level
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for FSH level
Time frame: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for FSH level
Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Sex hormone binding globulin (SHBG) level in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUC12 for SHBG level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC24 for SHBG level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: AUC48 for SHBG level
Time frame: Up to 48 hr after dosing in Part 1 and after first dosing in Part 2.
PD endpoint for ESN364: Cmin for SHBG level
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: tmin for SHBG level
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: AUCtau for SHBG level
Time frame: Before dosing on Day 10 in MD part of Part 2
PD endpoint for ESN364: Cpredose for SHBG level
Time frame: Before dosing in Part 1 and before dosing on Day 2, 3, 5, 7 and 10 in MD part of Part 2
PD endpoint for ESN364: Total testosterone (TT) level in plasma
Time frame: Up to 48 hr after dosing in Part 1, after first dosing in Part 2 and after dosing on Day 10 in MD part of Part 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ESN364 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by incidence of adverse events (AEs) in Part 1 (time frame: Up to Day 12 in Part 1). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.