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Clinical Trials/NCT03430661
NCT03430661
Completed
Phase 1

Single-center, Double-blind (ACT-246475), Open-label (Clopidogrel, Prasugrel, and Ticagrelor), Placebo-controlled, Randomized, Two-way Crossover Study to Investigate the Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of Clopidogrel or, Prasugrel, or Ticagrelor When Administered After a Single Subcutaneous Dose of the P2Y12 Antagonist ACT-246475 in Healthy Male and Female Subjects

Viatris Innovation GmbH1 site in 1 country77 target enrollmentStarted: January 24, 2018Last updated:
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ConditionsHealthy
InterventionsACT-246475ClopidogrelPlaceboPrasugrelTicagrelor
DrugsACT-246475ClopidogrelPrasugrelPlaceboTicagrelor

Overview

Phase
Phase 1
Status
Completed
Enrollment
77
Locations
1
Primary Endpoint
Time-matched comparisons of IPA% (MPA) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2, treatments are defined below) following administration of ACT-246475 and its matching placebo.
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The primary objective of this study is to assess the pharmacodynamic (PD) effects of clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.) dose of ACT-246475 in healthy male and female subjects

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Signed informed consent
  • •Healthy male and female subjects aged between 18 and 65 years (inclusive) at screening
  • •Body mass index of 18.0 to 31.0 kg/m2 (inclusive) at Screening
  • •Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls from screening up to at least 30 days after last study treatment administration
  • •Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 beats per minute (bpm) (inclusive) at screening
  • •Healthy on the basis of physical examination, cardiovascular assessments, and laboratory tests
  • •Maximum (at peak) platelet aggregation ≥ 40% (light transmission aggregometry \[LTA\]) upon 20 μM adenosine diphosphate (ADP) activation at screening
  • •Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/adrenaline and collagen/ADP below the upper limit of normal range at screening

Exclusion Criteria

  • •Pregnant or lactating women
  • •Known hypersensitivity to ACT-246475, clopidogrel, prasugrel, ticagrelor, any of their excipients, or drugs of the same class
  • •Any contraindication to clopidogrel, prasugrel, or ticagrelor treatment
  • •Known hypersensitivity or allergy to natural rubber latex
  • •Platelet count \< 120 × 109 L-1 at Screening and Day -1
  • •Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect)
  • •Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs, P2Y12 receptor antagonists, or any medication with blood-thinning activity (i.e., injectable or oral anticoagulants) within 3 weeks prior to study treatment administration
  • •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Arms & Interventions

Part A: Group 1

Experimental

Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

Intervention: ACT-246475 (Drug)

Part A: Group 1

Experimental

Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

Intervention: Clopidogrel (Drug)

Part A: Group 1

Experimental

Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

Intervention: Placebo (Drug)

Part A: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied

Intervention: ACT-246475 (Drug)

Part A: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied

Intervention: Clopidogrel (Drug)

Part A: Group 2

Experimental

Clopidogrel will be administered 12 h after ACT-246475 or placebo

Intervention: ACT-246475 (Drug)

Part A: Group 2

Experimental

Clopidogrel will be administered 12 h after ACT-246475 or placebo

Intervention: Clopidogrel (Drug)

Part A: Group 2

Experimental

Clopidogrel will be administered 12 h after ACT-246475 or placebo

Intervention: Placebo (Drug)

Part A: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied

Intervention: Placebo (Drug)

Part B: Group 1

Experimental

Prasugrel will be administered 12 h after ACT-246475 or placebo

Intervention: ACT-246475 (Drug)

Part B: Group 1

Experimental

Prasugrel will be administered 12 h after ACT-246475 or placebo

Intervention: Prasugrel (Drug)

Part B: Group 1

Experimental

Prasugrel will be administered 12 h after ACT-246475 or placebo

Intervention: Placebo (Drug)

Part B: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

Intervention: ACT-246475 (Drug)

Part B: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

Intervention: Prasugrel (Drug)

Part B: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

Intervention: Placebo (Drug)

Part B: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

Intervention: ACT-246475 (Drug)

Part B: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

Intervention: Prasugrel (Drug)

Part B: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied

Intervention: Placebo (Drug)

Part C: Group 1

Experimental

Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

Intervention: ACT-246475 (Drug)

Part C: Group 1

Experimental

Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

Intervention: Placebo (Drug)

Part C: Group 1

Experimental

Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax

Intervention: Ticagrelor (Drug)

Part C: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

Intervention: ACT-246475 (Drug)

Part C: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

Intervention: Placebo (Drug)

Part C: Group 2

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

Intervention: Ticagrelor (Drug)

Part C: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

Intervention: ACT-246475 (Drug)

Part C: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

Intervention: Placebo (Drug)

Part C: Group 3

Experimental

Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied

Intervention: Ticagrelor (Drug)

Outcomes

Primary Outcomes

Time-matched comparisons of IPA% (MPA) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2, treatments are defined below) following administration of ACT-246475 and its matching placebo.

Time Frame: From baseline up to 48 hours

- IPA%\[MPA\] will be calculated as mean change in percentage from baseline for each time point.

Time-matched comparisons of IPA %(PRU) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2) following administration of ACT-246475 and its matching placebo.

Time Frame: From baseline up to 48 hours

- IPA%\[PRU\] will be calculated as mean change in percentage from baseline for each time point. Treatment A1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of clopidogrel (600 mg). Treatment A2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of clopidogrel (300 mg). Treatment B1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of prasugrel (60 mg). Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of prasugrel (60 mg). Treatment C1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of ticagrelor (180 mg). Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of ticagrelor (180 mg).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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