A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects

• Sponsor: Idorsia Pharmaceuticals Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05480475
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Days): 28
• Patients Per Site Per Month: 26.1

Study Details

Study Description

Brief Summary

A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of dabigatran and rosuvastatin in healthy male subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Dabigatran etexilate; Drug: Rosuvastatin; Drug: Daridorexant	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: Three-period, fixed-sequence designThree-period, fixed-sequence design
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Single-center, Open-label, Three-period, Fixed-sequence Design Study to Investigate the Effect of Daridorexant on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Male Subjects
• Anticipated Study Start Date: Sep 2, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Study treatment (Period 1, 2, and 3) Period 1: Treatment A1 - dabigatran etexilate; Treatment A2 - rosuvastatin Period 2: Treatment B - daridorexant Period 3: Treatment C1 - dabigatran etexilate and daridorexant; Treatment C2 - rosuvastatin and daridorexant

Drug: Dabigatran etexilate; On Day 1 (Treatment A1) and on Day 9 (Treatment C1) a single oral dose of 75 mg dabigatran etexilate will be administered under fasted conditions.; Drug: Rosuvastatin; On Day 3 (Treatment A2) and on Day 11 (Treatment C2) a single oral dose of 10 mg rosuvastatin will be administered under fasted conditions.; Drug: Daridorexant; On Day 7 and Day 8 (Treatment B), on Day 9 and Day 10 (Treatment C1), and on Day 11 through 14 (Treatment C2) subjects will receive 50 mg daridorexant o.d. under fasted conditions.

Outcome Measures

Primary Outcome Measures

1. Maximum plasma concentration (Cmax) of dabigatran [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

2. Cmax of rosuvastatin [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

Other Outcome Measures

1. Time to reach Cmax (tmax) of dabigatran [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

2. Tmax of rosuvastatin [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

3. Area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of dabigatran [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

4. AUC0-inf of rosuvastatin [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

5. Terminal half-life (t½) of dabigatran [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

6. T½ of rosuvastatin [Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days).]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.

2. Healthy male subject aged between 18 and 45 years (inclusive) at Screening.

Exclusion Criteria:

1. Known hypersensitivity to daridorexant, rosuvastatin, and/or dabigatran etexilate, or treatments of the same class, or any of its/their excipients.

2. Any history of hemorrhagic disease, whether or not hereditary.

3. Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding.

4. Activated partial thromboplastin time (aPTT) and/or thrombin time (TT) < 0.8 or > 1.2 at Screening.

5. Clinically relevant findings on the physical examination at Screening.

6. Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.

7. Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at Screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEPHA s.r.o.	Pilsen		Czechia	323 00

Sponsors and Collaborators

• Idorsia Pharmaceuticals Ltd.

Investigators

• Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Idorsia Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT05480475
• Other Study ID Numbers: ID-078-125
• First Posted: Jul 29, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Dabigatran; Rosuvastatin Calcium

Study Results

No Results Posted as of Aug 3, 2022