A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine

Purpose

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).

Conditions

  • Methamphetamine Intoxication
  • Methamphetamine Disorders
  • Methamphetamine Abuse

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 56 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).
  • Drug: Methamphetamine
    Methamphetamine HCl for intravenous administration
  • Drug: Sterile Saline
    Sterile Saline for intravenous administration
Active Comparator
Active 		Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103
  • Drug: Methamphetamine
    Methamphetamine HCl for intravenous administration
  • Drug: CS-1103
    CS-1103 for intravenous administration

Recruiting Locations

California Clinical Trials Medical Group
Glendale, California 91206
Contact:
Lev Gertsik, M.D.
888-228-7425
study.losangeles@parexel.com

More Details

Status
Recruiting
Sponsor
Clear Scientific, Inc.

Study Contact

Anna Del Rosario, B.S.
617-621-8500
adelrosario@clearsci.com