HealthyPhase 1NCT03430661
A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects
A Phase 1 study testing ACT-246475, Clopidogrel and Prasugrel in people with Healthy, run by Viatris Innovation GmbH at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACT-246475, Clopidogrel and Prasugrel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 29 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main 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
Main 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Healthy
- Being tested
- ACT-246475, Clopidogrel, Prasugrel, Placebo, Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-246475Drug
Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection
ClopidogrelDrug
Tablet for oral administration (300 or 600 mg)
PrasugrelDrug
Tablet for oral administration (60 mg)
PlaceboDrug
Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution
TicagrelorDrug
Tablet for oral administration (180 mg)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Group 1 | Experimental | Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax Receives: Drug: ACT-246475; Drug: Clopidogrel; Drug: Placebo |
| Part A: Group 2 | Experimental | Clopidogrel will be administered 12 h after ACT-246475 or placebo Receives: Drug: ACT-246475; Drug: Clopidogrel; Drug: Placebo |
| 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 Receives: Drug: ACT-246475; Drug: Clopidogrel; Drug: Placebo |
| Part B: Group 1 | Experimental | Prasugrel will be administered 12 h after ACT-246475 or placebo Receives: Drug: ACT-246475; Drug: Prasugrel; Drug: Placebo |
| 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 Receives: Drug: ACT-246475; Drug: Prasugrel; Drug: Placebo |
| 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 Receives: Drug: ACT-246475; Drug: Prasugrel; Drug: Placebo |
| Part C: Group 1 | Experimental | Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax Receives: Drug: ACT-246475; Drug: Placebo; Drug: Ticagrelor |
| 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 Receives: Drug: ACT-246475; Drug: Placebo; Drug: Ticagrelor |
| 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 Receives: Drug: ACT-246475; Drug: Placebo; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- IPA%[MPA] will be calculated as mean change in percentage from baseline for each time point.
Measured: From baseline up to 48 hours
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.
- 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).
Measured: From baseline up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start24 Jan 2018
- Primary completion20 May 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Innovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Viatris Innovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430661
- Sponsor's protocol ID
- ID-076-103
- Status last verified
- Nov 2022
- First submitted
- 30 Jan 2018
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schilling U, Dingemanse J, Dobrow M, Baumann M, Riederer MA, Juif PE, Ufer M. Insights from In Vitro and Clinical Data to Guide Transition from the Novel P2Y12 Antagonist Selatogrel to Clopidogrel, Prasugrel, and Ticagrelor. Thromb Haemost. 2021 Jun;121(6):755-766. doi: 10.1055/s-0040-1721773. Epub 2021 Jan 7.
PubMed 33412611
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03430661
- Acronym / sponsor ID
- ID-076-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: Group 1 | Experimental | Drug: ACT-246475, Drug: Clopidogrel, Drug: PlaceboClopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax |
| Part A: Group 2 | Experimental | Drug: ACT-246475, Drug: Clopidogrel, Drug: PlaceboClopidogrel will be administered 12 h after ACT-246475 or placebo |
| Part A: Group 3 | Experimental | Drug: ACT-246475, Drug: Clopidogrel, Drug: PlaceboAny time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied |
| Part B: Group 1 | Experimental | Drug: ACT-246475, Drug: Prasugrel, Drug: PlaceboPrasugrel will be administered 12 h after ACT-246475 or placebo |
| Part B: Group 2 | Experimental | Drug: ACT-246475, Drug: Prasugrel, Drug: PlaceboAny time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied |
| Part B: Group 3 | Experimental | Drug: ACT-246475, Drug: Prasugrel, Drug: PlaceboAny time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied |
| Part C: Group 1 | Experimental | Drug: ACT-246475, Drug: Placebo, Drug: TicagrelorTicagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax |
| Part C: Group 2 | Experimental | Drug: ACT-246475, Drug: Placebo, Drug: TicagrelorAny time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied |
| Part C: Group 3 | Experimental | Drug: ACT-246475, Drug: Placebo, Drug: TicagrelorAny time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-246475Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection | Drug | Part A: Group 1, Part A: Group 2, Part A: Group 3, Part B: Group 1, Part B: Group 2, Part B: Group 3, Part C: Group 1, Part C: Group 2, Part C: Group 3 |
| ClopidogrelTablet for oral administration (300 or 600 mg) | Drug | Part A: Group 1, Part A: Group 2, Part A: Group 3 |
| PrasugrelTablet for oral administration (60 mg) | Drug | Part B: Group 1, Part B: Group 2, Part B: Group 3 |
| PlaceboMatching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution | Drug | Part A: Group 1, Part A: Group 2, Part A: Group 3, Part B: Group 1, Part B: Group 2, Part B: Group 3, Part C: Group 1, Part C: Group 2, Part C: Group 3 |
| TicagrelorTablet for oral administration (180 mg) | Drug | Part C: Group 1, Part C: Group 2, Part C: Group 3 |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 33412611Schilling U, Dingemanse J, Dobrow M, Baumann M, Riederer MA, Juif PE, Ufer M. Insights from In Vitro and Clinical Data to Guide Transition from the Novel P2Y12 Antagonist Selatogrel to Clopidogrel, Prasugrel, and Ticagrelor. Thromb Haemost. 2021 Jun;121(6):755-766. doi: 10.1055/s-0040-1721773. Epub 2021 Jan 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Viatris Innovation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-246475, Clopidogrel and Prasugrel in people with Healthy, run by Viatris Innovation GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.