Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Participants with Treatment Emergent Adverse Events |
The distribution of adverse events (AEs) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. |
up to 26 days post-drug administration with a 30-day safety follow-up call |
|
Secondary |
Observed maximum plasma concentration (Cmax) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-t) will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-inf) will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Time of maximum observed drug concentration occurrence (Tmax) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Terminal rate constant (?z) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. ?z will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Terminal elimination half-life (T^1/2) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Total systemic clearance for intravenous administration (CL) for cocaine and benzoylecgonine (BE) |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics. |
Day 2, Day 10 |
|
Secondary |
Observed maximum plasma concentration (Cmax) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Area Under the plasma concentration-time Curve from the time 0 to the last observed quantifiable concentration (AUC(0-t)) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-t) will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Area Under the plasma concentration-time Curve From 0 To 12 Hours (AUC0-12) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC0-12 will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Time of maximum observed drug concentration occurrence (Tmax) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Trough plasma concentration (Ctrough) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Ctrough will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Terminal elimination half-life (T^1/2) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Terminal rate constant (?z) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. ?z will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Apparent clearance of the drug from plasma after oral administration (CL/F) for AFQ056 |
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL/F will be listed and summarized using descriptive statistics. |
Day 10 |
|
Secondary |
Visual Analog Scales (VAS) |
The VAS is a self-administered assessment evaluating the subjective effects of cocaine. Participants will use an electronic patient reported outcomes (ePRO) system to answer VAS. |
up through day 10 |
|
Secondary |
Brief Substance Craving Scale (BSCS) |
The BSCS is a self-administered assessment that asks the participant to rate his or her craving for cocaine. the BSCS used for this study is a modification of the State of Feelings and Cravings Questionnaire. Participants will use an electronic patient reported outcomes (ePRO) system to answer BSCS. |
up through Day 10 |
|