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 Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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

Eligibility Criteria

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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.

Contacts and Locations

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Locations

Czechia
Cepha s.r.o.
Pilsen, Czechia, 32300

Sponsors and Collaborators

Idorsia Pharmaceuticals Ltd.

Investigators

Study Director:	Clemens Mühlan	Idorsia Pharmaceuticals Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT03339752 History of Changes
Other Study ID Numbers:	ID-078-106
First Posted:	November 13, 2017
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