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Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

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ClinicalTrials.gov Identifier: NCT03198624
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Heptares Therapeutics Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Safety Issues Pharmacokinetics Drug: HTL0018318 Drug: Placebo oral capsule Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Part A open label, Part B double blind.
Primary Purpose: Treatment
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
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : August 20, 2017
Actual Study Completion Date : August 20, 2017

Arm Intervention/treatment
Active Comparator: HTL0018318 Low dose, Part A.
Part A. 1 single dose on day 1. Discharged on day 4 of Period 1 (following 10 day washout).
Drug: HTL0018318
Part A single dose Part B five doses

Active Comparator: HTL0018318 High dose, Part A
1 single dose on day 1. Discharged on day 4 of period 2 (following 10 day washout).
Drug: HTL0018318
Part A single dose Part B five doses

Active Comparator: HTL0018318 Low dose, Part B
1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 1.
Drug: HTL0018318
Part A single dose Part B five doses

Placebo Comparator: Placebo oral capsule, Part B
1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 1.
Drug: Placebo oral capsule
Part B only
Other Name: placebo, placebo - cap

Active Comparator: HTL0018318 High dose, Part B.
1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 2.
Drug: HTL0018318
Part A single dose Part B five doses

Placebo Comparator: Placebo oral capsule, Part B.
1 dose daily for 5 days (5 active doses total). Discharged on day 8 of period 2.
Drug: Placebo oral capsule
Part B only
Other Name: placebo, placebo - cap




Primary Outcome Measures :
  1. Cmax [ Time Frame: Baseline to 72 hours ]
    Comparison of pharmacokinetics in plasma

  2. Tmax [ Time Frame: Baseline to 72 hours ]
    Comparison of pharmacokinetics in plasma

  3. Area under the curve [ Time Frame: Baseline to 72 hours ]
    Comparison of pharmacokinetics in plasma


Secondary Outcome Measures :
  1. Delay in absorption (Tlag) [ Time Frame: Baseline to 72 hours ]
    Pharmacokinetics in plasma

  2. Rate of elimination [ Time Frame: Baseline to 72 hours ]
    Pharmacokinetics in plasma

  3. Half life (t1/2) [ Time Frame: Baseline to 72 hours ]
    Pharmacokinetics in plasma

  4. Amount excreted in urine [ Time Frame: Baseline to 72 hours ]
    Pharmacokinetics in urine

  5. Fraction of dose eliminated unchanged in urine (fe/F) [ Time Frame: Baseline to 72 hours ]
    Pharmacokinetics in urine

  6. Treatment emergent adverse events (TEAEs) [ Time Frame: Up to 14 day post dose ]
    Safety and tolerability

  7. Number of participants with abnormal physical exam results [ Time Frame: Up to 14 day post dose ]
    Safety and tolerability

  8. Heart Rate [ Time Frame: Up to 14 day post dose ]
    Safety and tolerability

  9. Number of participants with abnormal laboratory values [ Time Frame: Up to 14 day post dose ]
    Safety and tolerability

  10. ECG [ Time Frame: Up to 14 day post dose ]
    Safety and tolerability

  11. Blood pressure [ Time Frame: Up to 14 day post dose ]
    Safety and tolerability



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male subjects, either Caucasian or Japanese aged ≥20 and ≤40 years.
  2. 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.
  3. 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.
  4. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
  5. 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.
  6. Satisfactory medical assessment with no clinically significant or relevant abnormalities.
  7. Able to perform spirometry/peak flow with a satisfactory technique at screening.
  8. 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.
  9. An understanding, ability, and willingness to fully comply with study procedures and restrictions

Exclusion Criteria:

  1. Any history of any condition associated with cognitive impairment, including but not limited to schizophrenia and dementia.
  2. History of epilepsy or seizures of any kind at any time.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. History of significant allergic reaction (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
  9. Has donated or lost 400 mL blood or more within the last 16 weeks preceding the first day of dosing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198624


Locations
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United Kingdom
Richmond Pharmacology
London, London Bridge, United Kingdom, SE1 1YR
Sponsors and Collaborators
Heptares Therapeutics Limited
Investigators
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Principal Investigator: Jorg Taubel, MD FFPM Richmond Pharmacology

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Responsible Party: Heptares Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03198624     History of Changes
Other Study ID Numbers: HTL0018318-105
2017-001245-27 ( EudraCT Number )
C17011 ( Other Identifier: Richmond Pharmacology )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No