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

NCT03785054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-04-29

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY
  • Nxera Pharma UK Limited

    lead INDUSTRY

Principal Investigators

  • Jim Bush, MBChB, PhD · Covance

  • Hamzah Malik · Covance

  • Robert Holland, BMBCh, DPhil · Heptares Therapeutics Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2021-03-11
Completion
2021-03-11

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 NCT03785054 on ClinicalTrials.gov