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 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: UTHSCSA-MCAM-101U01DA060704
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid Use Disorder

Keywords

Healthy participants; Opioid-experienced; μ-Opioid Receptor

Outcome Measures

Primary Outcomes (8)

• Part A (SAD): Cmax

  Maximum plasma concentration in the blood after administration

  Baseline to 120 hours

• Part A (SAD): Tmax

  Time to maximum concentration of drug in the blood

  Baseline to 120 hours

• Part A (SAD): T1/2

  Known as the "plasma half-life," this is the time required for the concentration of a substance (like a drug) in blood plasma to decrease by half its initial value.

  Baseline to 120 hours

• Part A (SAD): Area under the curve from 0-24 hours

  Area under the plasma concentration time curve from time 0 to 24 hours

  Baseline to 120 hours

• Part A (SAD): Area under the curve from 0-t

  Area under the plasma concentration time curve from time 0 to the last measurable concentration

  Baseline to 120 hours

• Part A (SAD): Area under the curve from 0-infinity

  Area Under the Curve from time zero to infinity (AUC 0-infinity) is a fundamental pharmacokinetic parameter representing the total drug exposure over time, from administration until the drug is completely eliminated. It measures the entire extent of absorption, distribution, metabolism, and excretion.

  Baseline to 120 hours

• Part B (Opioid-Experienced Cohort): Visual analog scale (VAS) of subjective drug effects

  Visual analog scales (VAS) are used in clinical trials to measure subjective drug effects, such as "liking," "high," or "good/bad effects" on a scale from 0 (strong dislike) to 100 (strong liking).

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

• Part B (Opioid-Experienced Cohort): pupillometry

  Measurement of pupil size

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

Secondary Outcomes (6)

• Part B (Opioid-Experienced Cohort): Cmax

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

• Part B (Opioid-Experienced Cohort): Tmax

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

• Part B (Opioid-Experienced Cohort): T1/2

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

• Part B (Opioid-Experienced Cohort): Area under the curve from 0-24 hours

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

• Part B (Opioid-Experienced Cohort): Area under the curve from 0-t

  Baseline to 24 hours for placebo and baseline to 216 hours for MCAM

Study Arms (3)

Part A Single Ascending Group (SAD) MCAM

EXPERIMENTAL

MCAM will be dosed orally using 3 dose levels: 3, 10 and 30 mg free base on Day 1.

Drug: MCAM

Part A Single Ascending Group Placebo

PLACEBO COMPARATOR

Participants in Part A randomized to placebo will receive 1% methylcellulose suspension on Day 1.

Other: Placebo

Part B: Opioid-Experienced Cohort

EXPERIMENTAL

Placebo will be dosed orally on Day 1 and MCAM will be dosed orally on Day 2. The dose level will be chosen based on the results of Part A (SAD).

Other: Placebo; Drug: MCAM

Interventions

Placebo OTHER

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

Also known as: Methylcellulose suspension

Part A Single Ascending Group Placebo; Part B: Opioid-Experienced Cohort

MCAM DRUG

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

Part A Single Ascending Group (SAD) MCAM; Part B: Opioid-Experienced Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is willing and able to provide informed consent and comply with all protocol requirements
• Is aged ≥18 years and ≤55 years at time of informed consent
• Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 and body weight (BW) not lower than 50 kg (Part A only)
• Participant is a nonsmoker (for at least 3 months prior to Screening) and does not use tobacco-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum) (Part A only)
• Has Blood pressure (BP) and Heart rate (HR) within the normal range at the Screening visit after 5 minutes in a seated position:
• Systolic BP between 90 and 145 mmHg
• Diastolic BP between 60 and 90 mmHg
• HR between 60 and 90 beats per minute
• Electrocardiogram (ECG) is normal based on 12-lead ECG assessment at Screening:
• ECG PR interval between 120 and 200 ms
• ECG QRS interval \<100 ms
• ECG QT interval (corrected) (QTc) with Fridericia formula (QTcF) \<450 ms for males and \<470 ms for females
• No sign of any sinus node dysfunction
• Has clinical laboratory parameters (hematology \[including coagulation\], clinical chemistry, and urinalysis) within normal ranges. Individual values out of the normal range may be acceptable if judged clinically insignificant by an Investigator.
• Has not been dosed in an interventional clinical drug trial within 30 days prior to screening or within 5 half-lives of the last dose of study drug, whichever is longer.

You may not qualify if:

• Any significant acute or uncontrolled medical illness
• Any history of cancer within 5 years of enrollment, with the exception of fully resected skin basal cell carcinoma
• Any major hospitalization or surgery 3 months prior to study drug administration
• Has donated or experienced a blood loss of 500 mL or more within 56 days prior to Screening or has donated plasma within 7 days prior to Screening
• Poor venous access assessed at Screening
• Has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence. If participation in a rehabilitation program was court-mandated as part of a plea agreement, entry may be permissible at an Investigator's discretion
• Any history of substance use disorder) as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5; e.g. a score of ≥2, within a 12-month period) or recent use of an opioid-containing product (e.g., codeine) within 6 months prior to study drug administration (Part A only)
• History of, or currently diagnosed with, any clinically significant psychiatric disorder (based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition \[DSM-5\] and Mini International Neuropsychiatric Interview \[MINI\] criteria), which in the opinion of an Investigator could interfere with study participation or study data collection (Part A only)
• History of any suicidal ideation within the past 6 months or a lifetime history of suicidal behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Any neurological, renal, cardiac, hepatic, or other medical condition that could interfere with study assessments as determined by and Investigator, or Sponsor
• Any significant illness or infection, as determined by an Investigator or Sponsor, within the prior 30 days
• Positive urine alcohol or urine drug screen for substance of abuse at Screening (Part A only)
• Must not be physically dependent on opioids, as demonstrated by successful completion of the naloxone challenge
• Known hypersensitivity to any component of the MCAM drug product, naloxone, or placebo
• Use of any prescription or over-the-counter medications (such as antacids, vitamins, minerals, dietary/herbal preparations, St. John's Wort, and nutritional supplements) within 14 days prior to Screening or 5 half-lives prior to the study

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Benjamin Sundling, DO

  Dr. Vince Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles France, PhD

CONTACT

210 567 6969; france@uthscsa.edu

Julia Taylor, PhD

CONTACT

210 567 0105; taylorj4@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In Part A, all study staff (including the safety evaluator) and participants will be blinded as to the administration of MCAM or placebo. Pharmacy staff will be unblinded. In Part B, administration of placebo and MCAM will be conducted in a single-blind manner where only participants are blind to treatment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase 1, first-in-human, placebo-controlled two-part study. Part A is a dose escalation to determine maximum tolerable dose and Part B will occur in opioid-experienced participants.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): July 8, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At study end, once the data is analyzed and published in a peer review journal

Locations

US (1)