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)

NCT03245229 | Completed Phase 1

• 1 other identifier: AC-080-106
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (6)

• Maximum plasma concentration (Cmax) of rosuvastatin

  Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

  Up to Day 29

• Time to reach Cmax (tmax) of rosuvastatin

  tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

  Up to Day 29

• Terminal half-life (t1/2) of rosuvastatin

  t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

  Up to Day 29

• Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin

  AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

  Up to Day 29

• Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin

  AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile

  Up to Day 29

• Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577

  Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile

  Up to Day 29

Secondary Outcomes (4)

• Number of participants with adverse events (AEs)

  Up to Day 29

• Changes from baseline in electrocardiogram (ECG) variables

  Up to Day 29

• Changes from baseline in blood pressure

  Up to Day 29

• Changes from baseline in pulse rate

  Up to Day 29

Study Arms (3)

Treatment A

EXPERIMENTAL

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

Drug: Rosuvastatin

Treatment B1

EXPERIMENTAL

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

Drug: Aprocitentan

Treatment B2

EXPERIMENTAL

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.

Drug: Aprocitentan; Drug: Rosuvastatin

Interventions

Aprocitentan DRUG

Capsule for oral administration

Also known as: ACT-132577

Treatment B1; Treatment B2

Rosuvastatin DRUG

Tablet for oral administration

Treatment A; Treatment B2

Eligibility Criteria

• Age: 18 Years - 45 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;
• Hemoglobin ≥ 135 g/L at screening.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Cepha s.r.o

Pilsen, 32300, Czechia

Location

MeSH Terms

Interventions

aprocitentan; Rosuvastatin Calcium

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

• Clinical Trial

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 10, 2017
• Study Start: August 10, 2017
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CZ (1)