Study to Assess Safety, Tolerability, and Interactions of Cocaine and Oral AFQ056

• Status: Withdrawn
• Trial end date: 2022-01-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to assess safety, tolerability and interactions of AFQ056 and cocaine in patients with cocaine use disorder.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: National Institute on Drug Abuse (NIDA)

Criteria

Key Inclusion Criteria:

• Non-treatment seeking participants who meet DSM-V criteria for cocaine use disorder as assessed using the Mini International Neuropsychiatric Interview (MINI) neuropsychiatric interview (version 7.0).

• Be between 18 and 55 years of age, inclusive

• Have a body mass index (BMI) within a range of 18.0 to 34.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.

• Have experience using cocaine by the smoked or IV route at least 6 times in the past 12 months prior to clinic intake (Day -3) and at least one use within the past 30 days.

• Provide a urine sample positive for cocaine at least once during screening (Days -28 to -4).

Key Exclusion Criteria:

• Have a current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.

• Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, paranoid reaction or seizure.

• Have clinically significant findings in the opinion of an investigator based on the MINI (version 7.0) neuropsychiatric interview.

• Be pregnant or lactating.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from at least 30 days prior to the first administration of study treatment (Day -2), while taking study treatment, and for at least 30 days after the last dose of the study treatment.

• Have a systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg and heart rate > 100 beats per minute at screening or clinic intake (Day -3).

• Have a history of liver or renal disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine, 1.5 × the upper limit of normal at screening or intake (Day -3).