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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

NCT ID: NCT03339752

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2017-12-02

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Rosuvastatin Day 1

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

10 mg tablet

Treatment B1

ACT-541468 Day 5 to Day 7

Group Type EXPERIMENTAL

ACT-541468

Intervention Type DRUG

25 mg hard capsule

Treatment B2

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

Group Type OTHER

Rosuvastatin

Intervention Type DRUG

10 mg tablet

ACT-541468

Intervention Type DRUG

25 mg hard capsule

Interventions

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Rosuvastatin

10 mg tablet

Intervention Type DRUG

ACT-541468

25 mg hard capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clemens Mühlan

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

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Cepha s.r.o.

Pilsen, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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ID-078-106

Identifier Type: -

Identifier Source: org_study_id