Healthy SubjectPhase 1NCT03814200
A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects
A Phase 1 study testing Saline, ACT-246475 and Rifampicin in people with Healthy Subject, run by Viatris Innovation GmbH at 1 site in Netherlands.
Trial summary
The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy 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 Subject
- What is being tested?
- Saline, ACT-246475 and Rifampicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Jan 2019to 19 Feb 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
Who may be able to join
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Healthy male and female subjects aged between 18 and 65 years (inclusive) at Screening
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1 of the first period
- Hematology and coagulation test results not deviating from the normal range to a clinically relevant extent at Screening and on Day -1 of the first period
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day- 1 of the first treatment period and must agree to consistently and correctly use a highly effective method of contraception
Who cannot join
- Previous exposure to ACT-246475.
- Previous exposure to rifampicin within 3 months prior to Screening.
- Known hypersensitivity to P2Y12 receptor antagonists or rifampicin, or to any of the rifamycins, or any of their excipients
- Loss of 250 mL or more of blood within 3 months prior to Screening
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers
- Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of a Single Intravenous Dose of Rifampicin on the Pharmacokinetics of ACT-246475 in Healthy Subjects
The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects
- Conditions
- Healthy Subject
- Being tested
- Saline, ACT-246475, Rifampicin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Single i.v. infusion of 100 mL saline 0.9% for 30 min
ACT-246475Drug
Also called Selatogrel
Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions
RifampicinDrug
Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min
| Study group | Role | What they receive |
|---|---|---|
| Treatment period A | Experimental | Treatment A1: saline 0.9%
followed by
Treatment A2: ACT-246475 Receives: Drug: Saline; Drug: ACT-246475 |
| Treatment period B | Experimental | Treatment B1: rifampicin
followed by
Treatment B2: ACT-246475 Receives: Drug: ACT-246475; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to 36 hours after treatment administration
AUC from zero to infinity (AUC0-inf)
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to 36 hours after treatment administration
The maximum plasma concentration (Cmax)
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to 36 hours after treatment administration
The time to reach Cmax (tmax)
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to 36 hours after treatment administration
Terminal half-life (t½)
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Measured: Up to 36 hours after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start3 Jan 2019
- Primary completion12 Feb 2019
- Study completion19 Feb 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 Healthy SubjectStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 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
- NCT03814200
- Sponsor's protocol ID
- ID-076-106
- Other IDs
- 2018-004226-28, 2018
- Status last verified
- Nov 2022
- First submitted
- 21 Jan 2019
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schilling U, Dingemanse J, Voors-Pette C, Romeijn C, Dogterom P, Ufer M. Effect of Rifampin-Mediated OATP1B1 and OATP1B3 Transporter Inhibition on the Pharmacokinetics of the P2Y12 Receptor Antagonist Selatogrel. Clin Transl Sci. 2020 Sep;13(5):886-890. doi: 10.1111/cts.12774. Epub 2020 Mar 31.
PubMed 32166864
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
- A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of a Single Intravenous Dose of Rifampicin on the Pharmacokinetics of ACT-246475 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03814200
- Acronym / sponsor ID
- ID-076-106
- Conditions
- Healthy Subject
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 23 Jan 2019 (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 study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment period A | Experimental | Drug: Saline, Drug: ACT-246475Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 |
| Treatment period B | Experimental | Drug: ACT-246475, Drug: RifampicinTreatment B1: rifampicin followed by Treatment B2: ACT-246475 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Healthy male and female subjects aged between 18 and 65 years (inclusive) at Screening
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1 of the first period
- Hematology and coagulation test results not deviating from the normal range to a clinically relevant extent at Screening and on Day -1 of the first period
Key exclusion criteria (7 listed)
- Previous exposure to ACT-246475.
- Previous exposure to rifampicin within 3 months prior to Screening.
- Known hypersensitivity to P2Y12 receptor antagonists or rifampicin, or to any of the rifamycins, or any of their excipients
- Loss of 250 mL or more of blood within 3 months prior to Screening
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
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 |
|---|---|---|
| SalineSingle i.v. infusion of 100 mL saline 0.9% for 30 min | Drug | Treatment period A |
| ACT-246475Also: SelatogrelSingle s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions | Drug | Treatment period A, Treatment period B |
| RifampicinSingle i.v. infusion of 600 mg rifampicin (100 mL) for 30 min | Drug | Treatment period B |
Primary outcome
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Time frame: Up to 36 hours after treatment administration
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to infinity (AUC0-inf)
Time frame: Up to 36 hours after treatment administration
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The maximum plasma concentration (Cmax)
Time frame: Up to 36 hours after treatment administration
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The time to reach Cmax (tmax)
Time frame: Up to 36 hours after treatment administration
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t½)
Time frame: Up to 36 hours after treatment administration
The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
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 32166864Schilling U, Dingemanse J, Voors-Pette C, Romeijn C, Dogterom P, Ufer M. Effect of Rifampin-Mediated OATP1B1 and OATP1B3 Transporter Inhibition on the Pharmacokinetics of the P2Y12 Receptor Antagonist Selatogrel. Clin Transl Sci. 2020 Sep;13(5):886-890. doi: 10.1111/cts.12774. Epub 2020 Mar 31.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 Saline, ACT-246475 and Rifampicin in people with Healthy Subject, run by Viatris Innovation GmbH at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. 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 Netherlands. 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?
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) (time frame: Up to 36 hours after treatment administration). The study lists 5 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 NCT03814200, 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.