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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339752
• Other study ID #: ID-078-106
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2017
• Last updated: December 8, 2017
• Start date: October 30, 2017
• Est. completion date: December 2, 2017

Study information

• Verified date: December 2017
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2, 2017
• Est. primary completion date: December 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Rosuvastatin
10 mg tablet
• ACT-541468
25 mg hard capsule

Locations

Country	Name	City	State
Czechia	Cepha s.r.o.	Pilsen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Effect of ACT-541468 at steady-state on AUC0-8 of single-dose rosuvastatin	Effect of ACT-541468 at steady-state on AUC0-8 of single-dose rosuvastatin	During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Treatment-emergent ECG abnormalities	Treatment-emergent ECG abnormalities during each treatment	From Screening to EOS (for a maximum of up to 5 weeks)
Secondary	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)
Secondary	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)