- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04935320
Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution
November 1, 2021 updated by: Heptares Therapeutics Limited
Phase 1, Randomised, Open-label, 3-period Crossover, Single Dose Study in Healthy Subjects, to Assess Relative Bioavailability From an Oral Capsule of HTL0016878 Citrate Salt Versus an Oral Solution of HTL0016878 Hydrochloride Salt
This is a randomised, open-label, 3-period, crossover single dose study to assess the relative bioavailability of two formulations of HTL0016878: an oral solution of HCl salt form (the reference product) and an oral capsule containing citrate salt (the test product); and of the effect of food on the pharmacokinetics of the capsule formulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fifteen healthy male or female subjects will be enrolled.
Each subject will have 3 study sessions and receive a single oral dose of 10 mg HTL0016878 on Day 1 of each study session.
Subjects will receive the HTL0016878.HCl oral solution in the fasted state in 1 session, and the HTL0016878.citrate
capsule, in the fasted state and after a high-fat meal, respectively, in the other 2 sessions.
Each subject will be randomised to 1 of 3 treatment sequences (5 subjects to each sequence).
There will be a washout of at least 10 days between doses.
Subjects will be screened within 35 days before their first dose of HTL0016878.
In each study session, subjects will be resident on the ward from the day before dosing (Day -1) until completion of procedures 72 h after their dose (Day 4).
Subjects will return for a follow up visit 10-13 days after their final dose of trial medication.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, NW10 7EW
- Hammersmith Medicines Research Ltd (HMR)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or females, aged 18-50 years
- Female subjects must agree to use highly effective contraception
- Weigh 60 kg or more, with a BMI in the range 18.0-30.0 kg/m2
- Sufficient intelligence to understand the nature of the trial
- Willingness to give written consent to participate
- Agree to use the contraception requirements of the trial
- Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System
Exclusion Criteria:
- Woman who is pregnant or lactating
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values
- Presence or history of acute or chronic illness, or mental health problem
- Impaired neurological, endocrine, thyroid, cardiovascular, respiratory, gastrointestinal, hepatic or renal function, diabetes mellitus, coronary heart disease, or history of any psychiatric disorder or psychotic mental illness
- Cancer during the 5 years before screening
- Supine blood pressure and heart rate outside the ranges: 90-140 mm Hg systolic and 50-90 mm Hg diastolic blood pressure; heart rate 45-80 beats/min
- Supine QT interval (QTcF) outside the ranges 300-450 msec (men) and 300-470 msec (women)
- Personal or family history of long QT syndrome or family sudden death
- Positive test for hepatitis B, hepatitis C or HIV
- Aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase or total bilirubin levels > 1.5 times the upper limit of normal
- Creatinine clearance < 80 mL/min/1.73 m2
- Presence or history of drug or alcohol abuse in the past 5 years; or regular intake of more than 21 units of alcohol weekly (for men) or 14 units of alcohol weekly (for women); or use of cigarettes, tobacco and/or nicotine-containing products during the 3 months before dosing
- Evidence of drug abuse or positive alcohol or cotinine test results
- Positive pregnancy test
- Habitual and heavy consumption of caffeinated beverages
- Use of a prescription or over-the-counter medicine, any herbal remedy, or nutritional supplement
- Receipt of a vaccine against COVID-19 in the 14 days before dosing
- Received live attenuated vaccination within 6 weeks prior to Screening
- History of severe allergies
- Use of any drugs that are inhibitors of CYP2D6
- Poor metaboliser of CYP2D6
- History of epilepsy or seizures
- Any disease associated with cognitive impairment and/or psychosis
- Suicidal thoughts or ideation, or insomnia
- Any history of mental illness (including anxiety, depression), which required medical intervention
- Presence or history of severe adverse reaction to any drug
- Surgery or medical condition that might affect absorption of medicines
- Receipt of an investigational product as part of another clinical trial within the 3 months before dosing in this study
- Receipt of HTL0016878 in a previous clinical trial
- Loss of more than 400 mL blood during the 3 months before dosing
- Unwilling to eat a high-fat breakfast
- Possibility that the volunteer will not cooperate with the requirements of the protocol
- Objection by GP to volunteer entering trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Solution Fasted
HTL0016878.HCl 10 mg, single dose, oral solution, fasted
|
Oral solution fasted
|
Experimental: Oral Capsule Fasted
HTL0016878.citrate 10 mg, single dose, oral capsule, fasted
|
Oral capsule fed or fasted
|
Experimental: Oral Capsule Fed
HTL0016878.citrate 10 mg, single dose, oral capsule, fed
|
Oral capsule fed or fasted
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of HTL0016878 in plasma Cmax
Time Frame: 0-72 hours
|
Pharmacokinetics
|
0-72 hours
|
Concentration of HTL0016878 in plasma AUC
Time Frame: 0-72 hours
|
Pharmacokinetics
|
0-72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Emergent Adverse Events
Time Frame: Baseline up to 13 days post-dose
|
Safety and Tolerability
|
Baseline up to 13 days post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2021
Primary Completion (Actual)
October 29, 2021
Study Completion (Actual)
October 29, 2021
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
June 21, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
November 2, 2021
Last Update Submitted That Met QC Criteria
November 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HTL0016878-102
- 18-018 (Hammersmith Medicines Research Ltd)
- 2018-003685-14 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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