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

NCT04935320 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-02-19

No results posted yet for this study

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

Interventions

DRUG

HTL0016878.HCl Solution 10 mg

Oral solution fasted

DRUG

HTL0016878.Citrate Capsule 10 mg

Oral capsule fed or fasted

Sponsors & Collaborators

  • Nxera Pharma UK Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2021-10-29
Completion
2021-10-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935320 on ClinicalTrials.gov