Status:
WITHDRAWN
Study to Assess Safety, Tolerability, and Interactions of Cocaine and Oral AFQ056
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a study to assess safety, tolerability and interactions of AFQ056 and cocaine in patients with cocaine use disorder.
Detailed Description
This is a randomized, participant- and investigator-blinded, placebo-controlled, parallel group study to assess safety and tolerability and to compare the effects of AFQ056 on IV cocaine's physiologic...
Eligibility Criteria
Inclusion
- Key
- 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
- 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).
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04771143
Start Date
July 21 2021
End Date
January 3 2022
Last Update
July 1 2021
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