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NCT07602335
Safety, Tolerability, and Pharmacokinetics of MCAM in Healthy Adult Participants
Conditions: Opioid Use Disorder
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: EARLY_PHASE1
Enrollment: 24
Sponsor: The University of Texas Health Science Center at San Antonio
Location: Dr. Vince Clinical Research Overland Park Kansas
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 aim is to measure blood levels of the study drug after oral administration.
Researchers will compare the active study drug to a placebo to test for any differences between the two groups.
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 4 days for treatment with either the study drug or placebo. They will attend a follow-up visit on Days 5 and 7 and participate in a follow-up phone call on Day 8. Three different doses will be tested to find the highest safe dose.
Eligibility Criteria
Inclusion Criteria:
1. Is willing and able to provide informed consent and comply with all protocol requirements
2. Is aged ≥18 years and ≤55 years at time of informed consent
3. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 and body weight (BW) not lower than 50 kg
4. 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)
5. Has Blood pressure (BP) and Heart rate (HR) within the normal range at the Screening visit after 5 minutes in a seated position:
1. Systolic BP between 90 and 145 mmHg
2. Diastolic BP between 60 and 90 mmHg
3. HR between 60 and 90 beats per minute
6. Electrocardiogram (ECG) is normal based on 12-lead ECG assessment at Screening:
1. ECG PR interval between 120 and 200 ms
2. ECG QRS interval \
Source: ClinicalTrials.gov (NCT07602335). StuddyBuddy aggregates publicly available trial information.