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
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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