Clinical trial NCT06721494: A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
Official title: A Phase 2 Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants With Methamphetamine Use Disorder Not Seeking Treatment Receiving a Single Dose of Methamphetamine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Methamphetamine Intoxication
Methamphetamine Disorders
Methamphetamine Abuse
Lead sponsor: Clear Scientific, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).


Eligibility criteria: Major Inclusion Criteria:

1. Healthy participants aged 18 to 55 years, inclusive;
2. Meets DSM-5 criteria for methamphetamine use disorder;
3. Not seeking treatment for methamphetamine use disorder;
4. Primary route of methamphetamine self-administration must be intravenous or smoking;
5. Able to abstain from methamphetamine without experiencing severe withdrawal;
6. A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 50 kg;
7. Females must not be lactating and must have a negative pregnancy test during screening and admission.

Major Exclusion Criteria:

1. Estimated glomerular filtration rate \<60 mL/min/1.73 m2;
2. History of cardiovascular disease;
3. Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
4. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.

Primary outcomes:
measure: Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
timeFrame: 3 days plus follow-up on Day 10
measure: Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
timeFrame: 3 days plus follow-up on Day 10
measure: Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
timeFrame: 3 days plus follow-up on Day 10
measure: Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
timeFrame: 3 days plus follow-up on Day 10
measure: Time course and magnitude of urine excretion of methamphetamine
timeFrame: 48 hours
Secondary outcomes:
measure: Time course of CS-1103 blood and urine concentrations
timeFrame: 48 hours
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
Study officials:
affiliation: Clear Scientific, Inc.
name: Xinhua Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: