NCT04506905

Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011)

A 2-Part Randomized Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Alternate MK-8189 Titration Regimens in Young Adult Participants With Schizophrenia and to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Elderly Participants With Schizophrenia and Healthy Elderly

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, 2-part clinical study of the safety, tolerability and pharmacokinetics of alternate MK-8189 titration regimens. Part 1 assessed multiple dose once-daily titration regimens of MK-8189 in young adult participants with schizophrenia. Part 2 assessed multiple once-daily doses of MK-8189 in elderly participants with schizophrenia and healthy elderly participants.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	MK-8189	MK-8189, oral, 4 mg and/or 12 mg tablets for a total daily dose of 8, 16 or 24 mg QD according to randomization
DRUG	Placebo	Oral tablets of dose-matched placebo to MK-8189 according to randomization

Timeline

• Start date: 2020-08-28
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2020-08-10
• Last updated: 2024-10-02
• Results posted: 2024-10-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study