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)

• Sponsor: Idorsia Pharmaceuticals Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03245229
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: ACT-132577; Drug: Rosuvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
• Actual Study Start Date: Aug 10, 2017
• Actual Primary Completion Date: Sep 18, 2017
• Actual Study Completion Date: Sep 18, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Rosuvastatin; Tablet for oral administration
Experimental: Treatment B1 25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12	Drug: ACT-132577; Capsule for oral administration
Experimental: 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.	Drug: ACT-132577; Capsule for oral administration; Drug: Rosuvastatin; Tablet for oral administration

Outcome Measures

Primary Outcome Measures

1. Maximum plasma concentration (Cmax) of rosuvastatin [Up to Day 29]

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

2. Time to reach Cmax (tmax) of rosuvastatin [Up to Day 29]

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

3. Terminal half-life (t1/2) of rosuvastatin [Up to Day 29]

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

4. Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin [Up to Day 29]

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

5. Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin [Up to Day 29]

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

6. Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577 [Up to Day 29]

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

Secondary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to Day 29]

   Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study

2. Changes from baseline in electrocardiogram (ECG) variables [Up to Day 29]

   ECG variables are to be recorded at rest using a standard 12-lead ECG

3. Changes from baseline in blood pressure [Up to Day 29]

   Blood pressure (mmHg) measured using an automatic oscillometric device

4. Changes from baseline in pulse rate [Up to Day 29]

   Pulse rate (bpm) measured using an automatic oscillometric device

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cepha s.r.o	Plzen		Czechia	32300

Sponsors and Collaborators

• Idorsia Pharmaceuticals Ltd.

Investigators

• Study Director: Milena Issac, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Idorsia Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT03245229
• Other Study ID Numbers: AC-080-106
• First Posted: Aug 10, 2017
• Last Update Posted: Jul 10, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rosuvastatin Calcium

Study Results

No Results Posted as of Jul 10, 2018