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A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin

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ClinicalTrials.gov Identifier: NCT03339752
Recruitment Status : Completed
First Posted : November 13, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Rosuvastatin Drug: ACT-541468 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : December 2, 2017
Actual Study Completion Date : December 2, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Treatment A
Rosuvastatin Day 1
Drug: Rosuvastatin
10 mg tablet
Experimental: Treatment B1
ACT-541468 Day 5 to Day 7
Drug: ACT-541468
25 mg hard capsule
Treatment B2
Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12
Drug: Rosuvastatin
10 mg tablet
Drug: ACT-541468
25 mg hard capsule



Primary Outcome Measures :
  1. Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin [ Time Frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. ]
    Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin

  2. Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin [ Time Frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. ]
    Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin

  3. Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin [ Time Frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. ]
    Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin

  4. Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin [ Time Frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. ]
    Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin

  5. Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin [ Time Frame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. ]
    Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin


Secondary Outcome Measures :
  1. Trough concentration (Ctrough) of ACT-541468 [ Time Frame: During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week ]
    Trough concentration (Ctrough) of ACT-541468

  2. Change in vital signs [ Time Frame: From Screening to EOS (for a maximum of up to 5 weeks) ]
    Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate)

  3. Change in ECG variables [ Time Frame: From Screening to EOS (for a maximum of up to 5 weeks) ]
    Change from baseline to each time point of measurement during each treatment in ECG variables

  4. Treatment-emergent (serious) adverse events [ Time Frame: From Screening to EOS (for a maximum of up to 5 weeks) ]
    Treatment-emergent AEs and SAEs during each treatment

  5. Treatment-emergent ECG abnormalities [ Time Frame: From Screening to EOS (for a maximum of up to 5 weeks) ]
    Treatment-emergent ECG abnormalities during each treatment

  6. Change in body weight [ Time Frame: From Screening to EOS (for a maximum of up to 5 weeks) ]
    Change from baseline to each time point of measurement during each treatment in body weight

  7. Change in clinical laboratory tests [ Time Frame: From Screening to EOS (for a maximum of up to 5 weeks) ]
    Change from baseline to each time point of measurement during each treatment in clinical laboratory tests



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent in the local language prior to any study mandated procedure;
  • Healthy male subjects aged 18 to 45 years (inclusive) at screening;
  • Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
  • Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

  • Known allergic reactions or hypersensitivity to ACT-541468, rosuvastatin, any drug of the same classes, or any of their excipients;
  • Any contraindication for rosuvastatin treatment;
  • History or clinical evidence of myopathy;
  • Asian or Indian-Asian ethnicity;
  • Known hypersensitivity or allergy to natural rubber latex;
  • Previous exposure to ACT-541468;
  • Treatment with rosuvastatin 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339752


Locations
Czechia
Cepha s.r.o.
Pilsen, Czechia, 32300
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
Study Director: Clemens Mühlan Idorsia Pharmaceuticals Ltd.

Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03339752     History of Changes
Other Study ID Numbers: ID-078-106
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors