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Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants and Onset and Duration of μ-Opioid Receptor Blockade by MCAM in Healthy, Adult, Opioid-Experienced Participants

NCT07602335 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-05-22

No results posted yet for this study

Summary

The goal of this clinical trial is to test the safety and to see if there are any side effects of the investigational drug, MCAM. The main questions are:

1. To measure blood levels of the study drug after oral administration
2. To test how quickly the study drug starts working and how long it works for

Researchers will compare the active study drug to a placebo to test for any differences between the two groups.

Part A (Single increasing dose):

Participants will be screened for up to 28 days before starting study treatment. Following the screening visit, participants will be admitted to a clinic for 2 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Day 5 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.

Part B (Opioid-experienced group):

Participants will be screened for up to 28 days followed by a 10-day in-clinic dosing and assessment period. They will also participate in a follow-up phone call on Day 13. The study drug will be given to participants on Day 2, based on results from Part A.

Conditions

Interventions

OTHER

Placebo

A 1% methylcellulose suspension will be dosed orally using an amber syringe to maintain blinding.

DRUG

MCAM

MCAM will be dosed orally as a 3, 10, or 30 mg suspension in an amber syringe to maintain blinding.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Benjamin Sundling, DO · Dr. Vince Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-07-08
Primary Completion
2027-05-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07602335 on ClinicalTrials.gov