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.
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
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)
Any significant acute or chronic 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
Parallel
Placebo
Other interventionA 1% methylcellulose solution will be dosed orally using an amber syringe to maintain blinding.
MCAM
DrugMCAM will be dosed orally as a 3, 10, or 30 mg suspension in an amber syringe to maintain blinding.
Single Ascending Dose (SAD): Cmax
Maximum plasma concentration in the blood after administration
SAD: Tmax
Time to maximum concentration of drug in the blood
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.
SAD: Area under the curve from 0-24 hours
Area under the plasma concentration time curve from time 0 to 24 hours
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
