A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-24

Study Completion Date

2019-05-29

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part A: Group 1

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Clopidogrel

Intervention Type DRUG

Tablet for oral administration (300 or 600 mg)

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Part A: Group 2

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Clopidogrel

Intervention Type DRUG

Tablet for oral administration (300 or 600 mg)

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Part A: Group 3

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Clopidogrel

Intervention Type DRUG

Tablet for oral administration (300 or 600 mg)

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Part B: Group 1

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Prasugrel

Intervention Type DRUG

Tablet for oral administration (60 mg)

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Part B: Group 2

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Prasugrel

Intervention Type DRUG

Tablet for oral administration (60 mg)

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Part B: Group 3

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Prasugrel

Intervention Type DRUG

Tablet for oral administration (60 mg)

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Part C: Group 1

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Ticagrelor

Intervention Type DRUG

Tablet for oral administration (180 mg)

Part C: Group 2

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Ticagrelor

Intervention Type DRUG

Tablet for oral administration (180 mg)

Part C: Group 3

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

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Placebo

Intervention Type DRUG

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Ticagrelor

Intervention Type DRUG

Tablet for oral administration (180 mg)

Interventions

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ACT-246475

Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection

Intervention Type DRUG

Clopidogrel

Tablet for oral administration (300 or 600 mg)

Intervention Type DRUG

Prasugrel

Tablet for oral administration (60 mg)

Intervention Type DRUG

Placebo

Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution

Intervention Type DRUG

Ticagrelor

Tablet for oral administration (180 mg)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes