NCT03785054

Phase 1, Healthy Subject, Safety, Tolerability and Pharmacokinetic Study of mGlu5 NAM HTL0014242

A Phase I, Randomised, Double-blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral HTL0014242 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Nxera Pharma UK Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is the first time HTL0014242 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when HTL0014242 is administered orally as single doses to healthy subjects. This information, together with the pharmacokinetics data, will help establish the doses and dosing regimen suitable for future studies in patients

Detailed description

This study will comprise a single dose, sequential group design. Overall, up to 72 subjects will be studied in up to 9 planned groups (Groups 1 to 9), with each group consisting of 8 subjects. In addition, a further 6 subjects will participate in a crossover food effect arm. Subjects will be screened within 28 days prior to dosing. Each subject will participate in 1 treatment period only, except the food effect arm where subjects will be dosed both fed and fasted. Subjects will reside at the clinical research unit from Day -1 (the day before dosing) to Day 5. All subjects will return for a follow-up visit 7 to 14 days after dosing. The investigator (or designee) may also request that the subject return for an additional follow up visit. In each of groups 1 to 9, 6 subjects will receive a single dose of HTL0014242 and 2 subjects will receive placebo oral capsule in accordance with a randomisation schedule. In the food effect arm, 6 subjects will receive a single dose of HTL0014242 in both the fed and fasted state, separated by 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HTL0014242	HTL0014242 is a selective negative allosteric modulator (NAM) for the metabotropic glutamate (mGlu) receptor 5 subtype (mGlu5)
DRUG	Placebo oral capsule	Placebo treatment

Timeline

• Start date: 2018-11-14
• Primary completion: 2021-03-11
• Completion: 2021-03-11
• First posted: 2018-12-24
• Last updated: 2021-04-29

Locations

1 site across 1 country: United Kingdom