A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)

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

2017-08-10

Study Completion Date

2017-09-18

Brief Summary

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The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects

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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

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

In the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Tablet for oral administration

Treatment B1

25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12

Group Type EXPERIMENTAL

Aprocitentan

Intervention Type DRUG

Capsule for oral administration

Treatment B2

In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h.

Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17.

Group Type EXPERIMENTAL

Aprocitentan

Intervention Type DRUG

Capsule for oral administration

Rosuvastatin

Intervention Type DRUG

Tablet for oral administration

Interventions

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Aprocitentan

Capsule for oral administration

Intervention Type DRUG

Rosuvastatin

Tablet for oral administration

Intervention Type DRUG

Other Intervention Names

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ACT-132577

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;
* Hemoglobin ≥ 135 g/L at screening.

Exclusion Criteria

* Known allergic reactions or hypersensitivity to ACT-132577, 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-132577;
* 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

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes