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

NCT03339752 | Completed Phase 1

• 1 other identifier: ID-078-106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Trough concentration (Ctrough) of ACT-541468

  During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week

• Change in vital signs

  From Screening to EOS (for a maximum of up to 5 weeks)

• Change in ECG variables

  From Screening to EOS (for a maximum of up to 5 weeks)

• Treatment-emergent (serious) adverse events

  From Screening to EOS (for a maximum of up to 5 weeks)

• Treatment-emergent ECG abnormalities

  From Screening to EOS (for a maximum of up to 5 weeks)

Study Arms (3)

Treatment A

ACTIVE COMPARATOR

Rosuvastatin Day 1

Drug: Rosuvastatin

Treatment B1

EXPERIMENTAL

ACT-541468 Day 5 to Day 7

Drug: ACT-541468

Treatment B2

OTHER

Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12

Drug: Rosuvastatin; Drug: ACT-541468

Interventions

Rosuvastatin DRUG

10 mg tablet

Treatment A; Treatment B2

ACT-541468 DRUG

25 mg hard capsule

Treatment B1; Treatment B2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Cepha s.r.o.

Pilsen, 32300, Czechia

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; daridorexant

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clemens Mühlan

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 13, 2017
• Study Start: October 30, 2017
• Primary Completion: December 2, 2017
• Study Completion: December 2, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)