HealthyPhase 1NCT03512548
Study in Healthy Subjects to Determine the Effect of an Inhibitor on Exposure to Relacorilant and Its Metabolites
A Phase 1 study testing Relacorilant 350mg, Itraconazole and Relacorilant 300mg in people with Healthy, run by Corcept Therapeutics at 1 site in United States.
Trial summary
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Relacorilant 350mg, Itraconazole and Relacorilant 300mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 23 Aug 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures.
- Give written informed consent.
- Be males or nonpregnant, nonlactating females judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight more than 50 kg (110 pounds).
- Be a nonsmoker. Use of nicotine or nicotine-containing products must be discontinued at least 90 days prior to the first dose of study drug.
- Be willing to comply with study restrictions
Show all 9Show fewer
- Have suitable veins for multiple venipuncture/cannulation.
- Female subjects must be either of nonchildbearing potential (ie, postmenopausal or permanently sterilized) or use highly effective contraception with low user-dependency.
- The only acceptable method of highly effective contraception with low user-dependency is an intrauterine device (IUD). Use of hormonal contraception (by any route, including intrauterine hormone releasing systems) or hormone replacement therapy is NOT acceptable.
Who cannot join
- Be an employee or immediate family member of the Clinical Research Unit or Corcept.
- Have been previously enrolled in any study of relacorilant.
- Have multiple drug allergies, or be allergic to any of the components of Relacorilant and/or itraconazole.
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition).
- Have a history of malabsorption syndrome or previous gastrointestinal surgery, with the exception of appendectomy and cholecystectomy, which could affect drug absorption or metabolism.
- Current alcohol or substance abuse.
Show all 20Show fewer
- In the 2 calendar months before first study drug administration, have donated/lost blood or plasma in excess of 400 mL.
- In the 30 days before first study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine.
- Have a positive test for alcohol or drugs of abuse at screening or first admission.
- Have clinically relevant abnormal findings on vital signs, physical examination, laboratory screening tests, or 12-lead ECG, at screening and/or before first study drug administration, including but not limited to**:
- QT interval corrected for heart rate (QTc) using Fridericia's equation (QTcF) >450 ms (from mean of 3 supine ECGs, performed at least 2 minutes apart)
- Stage 2 or higher hypertension (supine/semi-recumbent systolic blood pressure [SBP] >160 mmHg, diastolic blood pressure [DBP] >100 mmHg; based on mean of duplicate values recorded at least 2 minutes apart)
- Stage 1 hypertension (supine/semi-recumbent SBP 140-160 mmHg, DBP 90-100 mmHg; based on mean of duplicate values recorded at least 2 minutes apart) associated with indication for treatment ie, evidence of end-organ damage, diabetes, or a 10-year cardiovascular risk, estimated using a standard calculator, (eg, QRISK2-2016) greater than 20%
- Glomerular filtration rate, estimated using the chronic kidney disease epidemiology (collaboration) (CKD-EPI) method (eGFR; Levey 2009) <60 mL/minute/1.73 m2
- Hypokalemia (potassium below lower limit of normal)
- Alanine aminotransferase (ALT), aspartate amino transferase (AST), and/or gamma- glutamyltransferase (GGT) >1.5 times the upper limit of normal (ULN)
- Seropositive for hepatitis B, hepatitis C, or human immunodeficiency (HIV) viruses **For purposes of qualifying any given subject for study participation, out-of-range values may be repeated once.
- Have any medical or social reasons for not participating in the study raised by their primary care physician.
- Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator.
- Taken any prohibited prior medication within protocol designated timeframes, such as or including any glucocorticoid, strong inducers, inhibitors or substrates of CYP enzymes involved in drug-drug-interactions, hormonal contraception or hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Subjects to Determine the Effect of an Inhibitor of Cytochrome P450 3A on Exposure to Relacorilant and Its Main Metabolites
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.
If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.
Read the detailed description
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.
Part 2 of the study may be conducted if the results of Part 1 indicate that itraconazole has a clinically meaningful effect on exposure to relacorilant and metabolites. If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.
Blood samples will be collected before dosing and at intervals up to 96 hours after relacorilant dose in Part 1, and up to 24 hours after the last dose of relacorilant in each study period in Part 2. In Part 1 only, additional samples will be collected during the itraconazole dosing to confirm exposure.
Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead ECG recordings, vital signs, and and physical examinations.
Subjects will be admitted to the Clinical Research Unit (CRU) on the morning of Day -1 following an 8-hour fast for baseline assessments and will remain confined until completion of procedures. Each subject will have a follow-up (FU) visit 14 ± 2 days (Part 1) or 7 ± 2 days (Part 2) after the last dose of relacorilant.
- Conditions
- Healthy
- Being tested
- Relacorilant 350mg, Itraconazole, Relacorilant 300mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relacorilant 350mgDrug
Also called CORT125134
Relacorilant 350mg
ItraconazoleDrug
Also called Sporanox
Itraconazole 200 mg
Relacorilant 300mgDrug
Also called CORT125134
Relacorilant 300mg
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Period 1 | Experimental | Part 1 Period 1: Relacorilant 350mg will be given once on Day 1 Receives: Drug: Relacorilant 350mg |
| Part 1 Period 2 | Experimental | Part 1 Period 2: Itraconazole 200mg will be given for three days Receives: Drug: Itraconazole |
| Part 1 Period 3 | Experimental | Part 1 Period 3: Relacorilant 350mg will be given once with concomitant itraconazole and itraconazole will continue for three additional days Receives: Drug: Relacorilant 350mg; Drug: Itraconazole |
| Part 2 Period A | Experimental | Part 2 Period A: Relacorilant 300mg will be given once daily for 10 days Receives: Drug: Relacorilant 300mg |
| Part 2 Period B | Experimental | Part 2 Period B: Relacorilant 300mg will be given once daily in combination with itraconazole 200mg once daily for 10 days Receives: Drug: Itraconazole; Drug: Relacorilant 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Measured: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2
Secondary outcomes (3)
Area under plasma concentration-time curve extrapolated to infinity (AUCinf)
Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) areas under plasma concentration-time curve extrapolated to infinity (AUCinf)
Measured: predose to 96 hrs postdose in Part 1; AUCinf not calculated in Part 2 due to steady state evaluation
Maximum plasma concentration (Cmax)
Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) maximum plasma concentration (Cmax).
Measured: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2
Number and Severity of Treatment Emergent Adverse Events
Treatment Emergent Adverse Events will be summarized overall and by treatment based on their frequency and severity of treatment emergent adverse events
Measured: up to 7 weeks in Part 1 and up to 7 weeks in Part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start10 Apr 2018
- Primary completion29 Jul 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Custodio, PhD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512548
- Sponsor's protocol ID
- CORT125134-124
- Status last verified
- Mar 2020
- First submitted
- 3 Apr 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Sequence Crossover Study in Healthy Subjects to Determine the Effect of an Inhibitor of Cytochrome P450 3A on Exposure to Relacorilant and Its Main Metabolites
- ClinicalTrials.gov ID
- NCT03512548
- Acronym / sponsor ID
- CORT125134-124
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 30 Apr 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.
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.
If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.
Detailed description
This is an open label, single sequence, crossover study. In Part 1, eligible subjects will participate in 3 treatment periods, in which they will receive the following treatments in turn: 1) In Period 1, a single 350-mg dose of relacorilant administered alone, 2) In Period 2, once daily 200-mg doses of itraconazole administered for 3 days; 3) In Period 3, single 350-mg dose of relacorilant administered with a concomitant 200-mg dose of itraconazole and continued once daily 200-mg doses of itraconazole for three additional days.
Part 2 of the study may be conducted if the results of Part 1 indicate that itraconazole has a clinically meaningful effect on exposure to relacorilant and metabolites. If Part 2 is conducted, eligible subjects will participate in 2 treatment periods, in which they will receive the following treatments in turn: 1) In Period A, once daily 300-mg doses of relacorilant alone for 10 days; 2) In Period B, once daily 300-mg doses of relacorilant in combination with once daily 200-mg doses of itraconazole for 10 days.
Blood samples will be collected before dosing and at intervals up to 96 hours after relacorilant dose in Part 1, and up to 24 hours after the last dose of relacorilant in each study period in Part 2. In Part 1 only, additional samples will be collected during the itraconazole dosing to confirm exposure.
Safety and tolerability will be monitored using AEs, clinical laboratory evaluations, 12-lead ECG recordings, vital signs, and and physical examinations.
Subjects will be admitted to the Clinical Research Unit (CRU) on the morning of Day -1 following an 8-hour fast for baseline assessments and will remain confined until completion of procedures. Each subject will have a follow-up (FU) visit 14 ± 2 days (Part 1) or 7 ± 2 days (Part 2) after the last dose of relacorilant.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Period 1 | Experimental | Drug: Relacorilant 350mgPart 1 Period 1: Relacorilant 350mg will be given once on Day 1 |
| Part 1 Period 2 | Experimental | Drug: ItraconazolePart 1 Period 2: Itraconazole 200mg will be given for three days |
| Part 1 Period 3 | Experimental | Drug: Relacorilant 350mg, Drug: ItraconazolePart 1 Period 3: Relacorilant 350mg will be given once with concomitant itraconazole and itraconazole will continue for three additional days |
| Part 2 Period A | Experimental | Drug: Relacorilant 300mgPart 2 Period A: Relacorilant 300mg will be given once daily for 10 days |
| Part 2 Period B | Experimental | Drug: Itraconazole, Drug: Relacorilant 300mgPart 2 Period B: Relacorilant 300mg will be given once daily in combination with itraconazole 200mg once daily for 10 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able to understand the purpose and risks of the study; willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study evaluations and procedures.
- Give written informed consent.
- Be males or nonpregnant, nonlactating females judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings.
- Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a body weight more than 50 kg (110 pounds).
- Be a nonsmoker. Use of nicotine or nicotine-containing products must be discontinued at least 90 days prior to the first dose of study drug.
Key exclusion criteria (20 listed)
- Be an employee or immediate family member of the Clinical Research Unit or Corcept.
- Have been previously enrolled in any study of relacorilant.
- Have multiple drug allergies, or be allergic to any of the components of Relacorilant and/or itraconazole.
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition).
- Have a history of malabsorption syndrome or previous gastrointestinal surgery, with the exception of appendectomy and cholecystectomy, which could affect drug absorption or metabolism.
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 |
|---|---|---|
| Relacorilant 350mgAlso: CORT125134Relacorilant 350mg | Drug | Part 1 Period 1, Part 1 Period 3 |
| ItraconazoleAlso: SporanoxItraconazole 200 mg | Drug | Part 1 Period 2, Part 1 Period 3, Part 2 Period B |
| Relacorilant 300mgAlso: CORT125134Relacorilant 300mg | Drug | Part 2 Period A, Part 2 Period B |
Primary outcome
Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
Time frame: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2
Ratio of population geometric means (GMR) for Reference (following oral administration of relacorilant alone) and Test (following the same dose given to subjects concomitantly with itraconazole) areas under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz)
3 secondary outcomes
Area under plasma concentration-time curve extrapolated to infinity (AUCinf)
Time frame: predose to 96 hrs postdose in Part 1; AUCinf not calculated in Part 2 due to steady state evaluation
Maximum plasma concentration (Cmax)
Time frame: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2
Number and Severity of Treatment Emergent Adverse Events
Time frame: up to 7 weeks in Part 1 and up to 7 weeks in 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 24 Mar 2020.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Joseph Custodio, PhD study director
Corcept Therapeutics
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 Relacorilant 350mg, Itraconazole and Relacorilant 300mg in people with Healthy, run by Corcept Therapeutics at 1 site in United States.
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 9 inclusion and 20 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 24 Mar 2020. 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 United States. 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. 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?
Area under plasma concentration-time curve up to the last quantifiable sample (AUC0-tz) (time frame: predose to 96 hrs postdose in Part 1 and predose to 24 hrs after last dose in Part 2). 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 24 Mar 2020.