Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution

NCT04935320 | Completed Phase 1

• 3 other identifiers: HTL0016878-10218-0182018-003685-14
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 of the capsule formulation.

Conditions

Healthy Subjects

Keywords

Relative Bioavailability

Outcome Measures

Primary Outcomes (2)

• Concentration of HTL0016878 in plasma Cmax

  Pharmacokinetics

  0-72 hours

• Concentration of HTL0016878 in plasma AUC

  Pharmacokinetics

  0-72 hours

Secondary Outcomes (1)

• Treatment Emergent Adverse Events

  Baseline up to 13 days post-dose

Study Arms (3)

Oral Solution Fasted

EXPERIMENTAL

HTL0016878.HCl 10 mg, single dose, oral solution, fasted

Drug: HTL0016878.HCl Solution 10 mg

Oral Capsule Fasted

EXPERIMENTAL

HTL0016878.citrate 10 mg, single dose, oral capsule, fasted

Drug: HTL0016878.Citrate Capsule 10 mg

Oral Capsule Fed

EXPERIMENTAL

HTL0016878.citrate 10 mg, single dose, oral capsule, fed

Drug: HTL0016878.Citrate Capsule 10 mg

Interventions

HTL0016878.HCl Solution 10 mg DRUG

Oral solution fasted

Oral Solution Fasted

HTL0016878.Citrate Capsule 10 mg DRUG

Oral capsule fed or fasted

Oral Capsule Fasted; Oral Capsule Fed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nxera Pharma UK Limited: lead

Study Sites (1)

Hammersmith Medicines Research Ltd (HMR)

London, NW10 7EW, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 23, 2021
• Study Start: July 29, 2021
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)