Healthy SubjectsPhase 1NCT04935320
Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution
A Phase 1 study testing HTL0016878.HCl Solution 10 mg and HTL0016878.Citrate Capsule 10 mg in people with Healthy Subjects, run by Nxera Pharma UK Limited at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- HTL0016878.HCl Solution 10 mg and HTL0016878.Citrate Capsule 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jul 2021to 29 Oct 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research Ltd (HMR)
London, NW10 7EW
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- HTL0016878.HCl Solution 10 mg, HTL0016878.Citrate Capsule 10 mg
- Keywords
- Relative Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTL0016878.HCl Solution 10 mgDrug
Oral solution fasted
HTL0016878.Citrate Capsule 10 mgDrug
Oral capsule fed or fasted
| Study group | Role | What they receive |
|---|---|---|
| Oral Solution Fasted | Experimental | HTL0016878.HCl 10 mg, single dose, oral solution, fasted Receives: Drug: HTL0016878.HCl Solution 10 mg |
| Oral Capsule Fasted | Experimental | HTL0016878.citrate 10 mg, single dose, oral capsule, fasted Receives: Drug: HTL0016878.Citrate Capsule 10 mg |
| Oral Capsule Fed | Experimental | HTL0016878.citrate 10 mg, single dose, oral capsule, fed Receives: Drug: HTL0016878.Citrate Capsule 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HTL0016878 in plasma Cmax
Pharmacokinetics
Measured: 0-72 hours
Concentration of HTL0016878 in plasma AUC
Pharmacokinetics
Measured: 0-72 hours
Secondary outcomes (1)
Treatment Emergent Adverse Events
Safety and Tolerability
Measured: Baseline up to 13 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start29 Jul 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935320
- Sponsor's protocol ID
- HTL0016878-102
- Other IDs
- 18-018, 2018-003685-14, 2018
- Status last verified
- Feb 2025
- First submitted
- 21 Jun 2021
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04935320
- Acronym / sponsor ID
- HTL0016878-102
- Conditions
- Healthy Subjects
- Keywords
- Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nxera Pharma UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 23 Jun 2021 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Solution Fasted | Experimental | Drug: HTL0016878.HCl Solution 10 mgHTL0016878.HCl 10 mg, single dose, oral solution, fasted |
| Oral Capsule Fasted | Experimental | Drug: HTL0016878.Citrate Capsule 10 mgHTL0016878.citrate 10 mg, single dose, oral capsule, fasted |
| Oral Capsule Fed | Experimental | Drug: HTL0016878.Citrate Capsule 10 mgHTL0016878.citrate 10 mg, single dose, oral capsule, fed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (33 listed)
- 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
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 |
|---|---|---|
| HTL0016878.HCl Solution 10 mgOral solution fasted | Drug | Oral Solution Fasted |
| HTL0016878.Citrate Capsule 10 mgOral capsule fed or fasted | Drug | Oral Capsule Fasted, Oral Capsule Fed |
Primary outcome
Concentration of HTL0016878 in plasma Cmax
Time frame: 0-72 hours
Pharmacokinetics
Concentration of HTL0016878 in plasma AUC
Time frame: 0-72 hours
Pharmacokinetics
1 secondary outcome
Treatment Emergent Adverse Events
Time frame: Baseline up to 13 days 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 19 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 HTL0016878.HCl Solution 10 mg and HTL0016878.Citrate Capsule 10 mg in people with Healthy Subjects, 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 8 inclusion and 33 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 19 Feb 2025. 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. 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?
Concentration of HTL0016878 in plasma Cmax (time frame: 0-72 hours). The study lists 2 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 19 Feb 2025.