Safety IssuesPhase 1HTL0018318NCT03198624
Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
A Phase 1 study testing HTL0018318 in people with Safety Issues and Pharmacokinetics, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial summary
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Pharmacokinetics
- What is being tested?
- HTL0018318
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2017to 20 Aug 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects, either Caucasian or Japanese aged ≥20 and ≤40 years.
- Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese.
- The Caucasian subjects should be distinguished especially by very light to brown skin pigmentation and straight to wavy or curly hair, and should be indigenous to Europe, northern Africa and western Asia. Therefore, the study may include Caucasian subjects from North America, New Zealand, Australia and South Africa.
- Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
- Male subjects, if heterosexually active and with a female partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least 3 months after the end of the systemic exposure of the study drug.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities.
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- Able to perform spirometry/peak flow with a satisfactory technique at screening.
- Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the International Council of Harmonization Good Clinical Practice (GCP) Guideline E6.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions
Who cannot join
- Any history of any condition associated with cognitive impairment, including but not limited to schizophrenia and dementia.
- History of epilepsy or seizures of any kind at any time.
- Current or relevant history of any physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise related clinically significant cardiac events.
- Presence or history of drug or alcohol abuse in the last 5 years, or the inability to refrain from alcohol use from 48 hours before screening, dosing and each scheduled visit until the end of the study.
- Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, electronic cigarettes) within 3 months prior to the planned first day of dosing.
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- Use of prescription medications within 14 days or 10 half-lives (whichever is longer) prior to Day 1 of the dosing period, or any over-the-counter (OTC) medication (including multivitamin, herbal, or homeopathic preparations, excluding hormonal contraception, hormone-replacement therapy, and/or an occasional dose of acetaminophen) within 7 days prior to Day 1 of the dosing period.
- History of significant allergic reaction (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
- Has donated or lost 400 mL blood or more within the last 16 weeks preceding the first day of dosing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology
London, London Bridge, SE1 1YR
About this study
Official title: A Two-part, Single and Multiple Dose, Parallel Group Study to Assess Safety and Pharmacokinetics of Oral HTL0018318 in Healthy Japanese and Caucasian Subjects
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
Read the detailed description
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. The study will be conducted in two parts: (A) single doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects; (B) multiple doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects.
- Conditions
- Safety Issues, Pharmacokinetics
- Being tested
- HTL0018318, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0018318Drug
Part A single dose Part B five doses
Placebo oral capsuleDrug
Also called placebo, placebo - cap
Part B only
| Study group | Role | What they receive |
|---|---|---|
| HTL0018318 Low dose, Part A. | Active comparator | Part A. 1 single dose on day 1. Discharged on day 4 of Period 1 (following 10 day washout). Receives: Drug: HTL0018318 |
| HTL0018318 High dose, Part A | Active comparator | 1 single dose on day 1. Discharged on day 4 of period 2 (following 10 day washout). Receives: Drug: HTL0018318 |
| HTL0018318 Low dose, Part B | Active comparator | 1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 1. Receives: Drug: HTL0018318 |
| Placebo oral capsule, Part B | Placebo comparator | 1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 1. Receives: Drug: Placebo oral capsule |
| HTL0018318 High dose, Part B. | Active comparator | 1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 2. Receives: Drug: HTL0018318 |
| Placebo oral capsule, Part B. | Placebo comparator | 1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 2. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Comparison of pharmacokinetics in plasma
Measured: Baseline to 72 hours
Tmax
Comparison of pharmacokinetics in plasma
Measured: Baseline to 72 hours
Area under the curve
Comparison of pharmacokinetics in plasma
Measured: Baseline to 72 hours
Secondary outcomes (11)
Delay in absorption (Tlag)
Pharmacokinetics in plasma
Measured: Baseline to 72 hours
Rate of elimination
Pharmacokinetics in plasma
Measured: Baseline to 72 hours
Half life (t1/2)
Pharmacokinetics in plasma
Measured: Baseline to 72 hours
Amount excreted in urine
Pharmacokinetics in urine
Measured: Baseline to 72 hours
Fraction of dose eliminated unchanged in urine (fe/F)
Pharmacokinetics in urine
Measured: Baseline to 72 hours
Treatment emergent adverse events (TEAEs)
Safety and tolerability
Measured: Up to 14 day post dose
Number of participants with abnormal physical exam results
Safety and tolerability
Measured: Up to 14 day post dose
Heart Rate
Safety and tolerability
Measured: Up to 14 day post dose
Number of participants with abnormal laboratory values
Safety and tolerability
Measured: Up to 14 day post dose
ECG
Safety and tolerability
Measured: Up to 14 day post dose
Blood pressure
Safety and tolerability
Measured: Up to 14 day post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start16 May 2017
- Primary completion20 Aug 2017
- Study completion20 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorg Taubel, MD FFPM, Principal investigator, Richmond Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198624
- Sponsor's protocol ID
- HTL0018318-105
- Other IDs
- 2017-001245-27, C17011, 2017
- Acronym
- HTL0018318
- Status last verified
- Sep 2017
- First submitted
- 19 Jun 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Single and Multiple Dose, Parallel Group Study to Assess Safety and Pharmacokinetics of Oral HTL0018318 in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03198624
- Acronym / sponsor ID
- HTL0018318 / HTL0018318-105
- Conditions
- Safety Issues, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 May 2017 (actual)
- Primary completion
- 20 Aug 2017 (actual)
- Study completion
- 20 Aug 2017 (actual)
- First posted
- 26 Jun 2017 (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 a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
Detailed description
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. The study will be conducted in two parts: (A) single doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects; (B) multiple doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HTL0018318 Low dose, Part A. | Active comparator | Drug: HTL0018318Part A. 1 single dose on day 1. Discharged on day 4 of Period 1 (following 10 day washout). |
| HTL0018318 High dose, Part A | Active comparator | Drug: HTL00183181 single dose on day 1. Discharged on day 4 of period 2 (following 10 day washout). |
| HTL0018318 Low dose, Part B | Active comparator | Drug: HTL00183181 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 1. |
| Placebo oral capsule, Part B | Placebo comparator | Drug: Placebo oral capsule1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 1. |
| HTL0018318 High dose, Part B. | Active comparator | Drug: HTL00183181 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 2. |
| Placebo oral capsule, Part B. | Placebo comparator | Drug: Placebo oral capsule1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 2. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male subjects, either Caucasian or Japanese aged ≥20 and ≤40 years.
- Japanese subjects must have lived outside of Japan for ≤ 5 years in total and be first generation Japanese, defined as born in Japan and having 4 biologic grandparents who are ethnic Japanese.
- The Caucasian subjects should be distinguished especially by very light to brown skin pigmentation and straight to wavy or curly hair, and should be indigenous to Europe, northern Africa and western Asia. Therefore, the study may include Caucasian subjects from North America, New Zealand, Australia and South Africa.
- Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
- Male subjects, if heterosexually active and with a female partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least 3 months after the end of the systemic exposure of the study drug.
Key exclusion criteria (9 listed)
- Any history of any condition associated with cognitive impairment, including but not limited to schizophrenia and dementia.
- History of epilepsy or seizures of any kind at any time.
- Current or relevant history of any physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
- The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise related clinically significant cardiac events.
- Presence or history of drug or alcohol abuse in the last 5 years, or the inability to refrain from alcohol use from 48 hours before screening, dosing and each scheduled visit until the end of the study.
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 |
|---|---|---|
| HTL0018318Part A single dose Part B five doses | Drug | HTL0018318 High dose, Part A, HTL0018318 High dose, Part B., HTL0018318 Low dose, Part A., HTL0018318 Low dose, Part B |
| Placebo oral capsuleAlso: placebo, placebo - capPart B only | Drug | Placebo oral capsule, Part B, Placebo oral capsule, Part B. |
Primary outcome
Cmax
Time frame: Baseline to 72 hours
Comparison of pharmacokinetics in plasma
Tmax
Time frame: Baseline to 72 hours
Comparison of pharmacokinetics in plasma
Area under the curve
Time frame: Baseline to 72 hours
Comparison of pharmacokinetics in plasma
11 secondary outcomes
Delay in absorption (Tlag)
Time frame: Baseline to 72 hours
Rate of elimination
Time frame: Baseline to 72 hours
Half life (t1/2)
Time frame: Baseline to 72 hours
Amount excreted in urine
Time frame: Baseline to 72 hours
Fraction of dose eliminated unchanged in urine (fe/F)
Time frame: Baseline to 72 hours
Treatment emergent adverse events (TEAEs)
Time frame: Up to 14 day post dose
Number of participants with abnormal physical exam results
Time frame: Up to 14 day post dose
Heart Rate
Time frame: Up to 14 day post dose
Number of participants with abnormal laboratory values
Time frame: Up to 14 day post dose
ECG
Time frame: Up to 14 day post dose
Blood pressure
Time frame: Up to 14 day post dose
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 7 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Jorg Taubel, MD FFPM principal investigator
Richmond Pharmacology
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 HTL0018318 in people with Safety Issues and Pharmacokinetics, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
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 9 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 7 Sep 2017. 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 Kingdom. 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?
Cmax (time frame: Baseline to 72 hours). The study lists 3 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 7 Sep 2017.