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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Rosuvastatin; Drug: ACT-541468

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Pilsen, Czechia, 32300
    • CEPHA s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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
Other: Treatment B2; Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12	Drug: Rosuvastatin; 10 mg tablet; Drug: ACT-541468; 25 mg hard capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin	Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin	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	Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin	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	Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin	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	Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin	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	Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin	During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough concentration (Ctrough) of ACT-541468	Trough concentration (Ctrough) of ACT-541468	During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week
Change in vital signs	Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate)	From Screening to EOS (for a maximum of up to 5 weeks)
Change in ECG variables	Change from baseline to each time point of measurement during each treatment in ECG variables	From Screening to EOS (for a maximum of up to 5 weeks)
Treatment-emergent (serious) adverse events	Treatment-emergent AEs and SAEs during each treatment	From Screening to EOS (for a maximum of up to 5 weeks)
Treatment-emergent ECG abnormalities	Treatment-emergent ECG abnormalities during each treatment	From Screening to EOS (for a maximum of up to 5 weeks)
Change in body weight	Change from baseline to each time point of measurement during each treatment in body weight	From Screening to EOS (for a maximum of up to 5 weeks)
Change in clinical laboratory tests	Change from baseline to each time point of measurement during each treatment in clinical laboratory tests	From Screening to EOS (for a maximum of up to 5 weeks)

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Clemens Mühlan, Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): December 2, 2017
• Study Completion (Actual): December 2, 2017

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: ID-078-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No