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A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects

Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03814200
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
1.5
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Jan 3, 2019
Actual Primary Completion Date :
Feb 12, 2019
Actual Study Completion Date :
Feb 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment period A

Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475

Drug: Saline
Single i.v. infusion of 100 mL saline 0.9% for 30 min

Drug: ACT-246475
Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions
Other Names:
  • Selatogrel

    		•
    Experimental: Treatment period B

    Treatment B1: rifampicin followed by Treatment B2: ACT-246475

    Drug: ACT-246475
    Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions
    Other Names:
  • Selatogrel

    • Drug: Rifampicin
    Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min

    Outcome Measures

    Primary Outcome Measures

    1. 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) [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

    2. AUC from zero to infinity (AUC0-inf) [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

    3. The maximum plasma concentration (Cmax) [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

    4. The time to reach Cmax (tmax) [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

    5. Terminal half-life (t½) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 QPS Netherlands B.V. Groningen Netherlands 9700

    Sponsors and Collaborators

    • Idorsia Pharmaceuticals Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Idorsia Pharmaceuticals Ltd.
    ClinicalTrials.gov Identifier:
    NCT03814200
    Other Study ID Numbers:
    • ID-076-106
    • 2018-004226-28
    First Posted:
    Jan 23, 2019
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rifampin

    Study Results

    No Results Posted as of Feb 2, 2022