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The study has been terminated due to difficulties in recruiting subjects into Part C. No safety concerns contributed to the termination of the study
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The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults
The study is designed in three parts, A, B and C
Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose
Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose
Part C: single-center, open-label, single dose in CYP2C9 poor metabolizers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-084, single ascending dose (Part A) | Experimental | AC-084 administered at different single dose levels in a sequential manner, and in a maximum of 7 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo) |
|
| Placebo,single ascending dose (Part A) | Placebo Comparator | Matched placebo administered as single ascending doses in parallel to AC-084 |
|
| AC-084, multiple ascending dose (Part B) | Experimental | AC-084 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be between 1 and 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A. Each dose level will be investigated in a new group of at least 8 healthy male subjects (6 on active drug and 2 on placebo) |
|
| Placebo,multiple ascending dose (Part B) | Placebo Comparator | Matched placebo administered as multiple ascending doses in parallel to AC-084 |
|
| AC-084, single dose (Part C) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-084 | Drug | Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) (Part A) | Treatment-emergent AEs and treatment-emergent serious AEs | From dosing until day 4 |
| Number of participants with adverse events (AEs) (Part B) | Treatment-emergent AEs and treatment-emergent serious AEs | From dosing until day 8 |
| Number of participants with adverse events (AEs) (Part C) | Treatment-emergent AEs and treatment-emergent serious AEs | From dosing until day 6 |
| Incidence of safety events of interest (Part A) | Events of interest are any abnormalities in ECG, vital signs or laboratory test results | From dosing until day 4 |
| Incidence of safety events of interest (Part B) | Events of interest are any abnormalities in ECG, vital signs or laboratory test results | From dosing until day 8 |
| Incidence of safety events of interest (Part C) | Events of interest are any abnormalities in ECG, vital signs or laboratory test results | From dosing until day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) following single oral ascending doses (Part A) | Cmax is derived from the observed plasma concentration-time curves | From dosing until day 4 |
| Maximum plasma concentration (Cmax) following single oral ascending doses (Part B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine Géhin, PhD | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Leeds | LS2 9LH | United Kingdom |
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Up to 6 subjects in part C will receive AC-084 administered at a single dose (foreseen to be 100 mg) |
|
| Placebo | Drug | Placebo capsules matching AC-084 capsules |
|
Cmax is derived from the observed plasma concentration-time curves |
| From dosing until day 8 |
| Maximum plasma concentration (Cmax) following single oral ascending doses (Part C) | Cmax is derived from the observed plasma concentration-time curves | From dosing until day 6 |
| Time to reach Cmax (tmax) following single oral ascending doses (Part A) | Tmax is derived from the observed plasma concentration-time curves | From dosing until day 4 |
| Time to reach Cmax (tmax) following single oral ascending doses (Part B) | Tmax is derived from the observed plasma concentration-time curves | From dosing until day 8 |
| Time to reach Cmax (tmax) following single oral ascending doses (Part C) | Tmax is derived from the observed plasma concentration-time curves | From dosing until day 6 |
| Terminal half-life [t(1/2)] following single oral ascending doses (Part A) | From dosing until day 4 |
| Terminal half-life [t(1/2)] following single oral ascending doses (Part B) | From dosing until day 8 |
| Terminal half-life [t(1/2)] following single oral ascending doses (Part C) | From dosing until day 6 |
| Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part A) | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity | From dosing until day 4 |
| Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part B) | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity | From dosing until day 8 |
| Area under the plasma concentration-time curve (AUC) following single oral ascending doses (Part C) | AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity | From dosing until day 6 |