NCT05953740

A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Long-Acting Injectable of MK-5720 in Participants With Schizophrenia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending intramuscular doses of MK-5720, and the safety and tolerability of multiple once-daily oral doses of MK-8189, in participants with schizophrenia. The primary study hypothesis is that the administration of MK-5720 is safe and well tolerated.

Detailed description

In Period 1, participants receive once-daily MK-8189 for 7 days, followed by a 72-hour washout. In Period 2, participants receive a single dose of MK-5720.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	MK-5720	IM injection
DRUG	Placebo to MK-5720	Placebo IM Injection matched to MK-5720
DRUG	MK-8189	Oral Tablet
DRUG	Placebo to MK-8189	Placebo oral tablet matched to MK-8189

Timeline

• Start date: 2023-09-15
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2023-07-20
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study