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

NCT05480475 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-125
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (6)

• 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).

• 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).

• 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).

Study Arms (1)

Study treatment (Period 1, 2, and 3)

EXPERIMENTAL

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; Drug: Rosuvastatin; Drug: Daridorexant

Interventions

Dabigatran etexilate DRUG

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.

Study treatment (Period 1, 2, and 3)

Rosuvastatin DRUG

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.

Study treatment (Period 1, 2, and 3)

Daridorexant DRUG

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.

Study treatment (Period 1, 2, and 3)

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 a language understandable to the subject prior to any study-mandated procedure.
• Healthy male subject aged between 18 and 45 years (inclusive) at Screening.

You may not qualify if:

• Known hypersensitivity to daridorexant, rosuvastatin, and/or dabigatran etexilate, or treatments of the same class, or any of its/their excipients.
• Any history of hemorrhagic disease, whether or not hereditary.
• Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding.
• Activated partial thromboplastin time (aPTT) and/or thrombin time (TT) \< 0.8 or \> 1.2 at Screening.
• Clinically relevant findings on the physical examination at Screening.
• Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.
• Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at Screening.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

CEPHA s.r.o.

Pilsen, 323 00, Czechia

Location

Related Publications (1)

• Anliker-Ort M, Dingemanse J, Janu L, Kaufmann P. Effect of Daridorexant on the Pharmacokinetics of P-Glycoprotein Substrate Dabigatran Etexilate and Breast Cancer Resistance Protein Substrate Rosuvastatin in Healthy Subjects. Clin Drug Investig. 2023 Nov;43(11):827-837. doi: 10.1007/s40261-023-01310-6. Epub 2023 Oct 19.

  PMID: 37858005 DERIVED

MeSH Terms

Interventions

Dabigatran; Rosuvastatin Calcium; daridorexant

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three-period, fixed-sequence design

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: September 3, 2022
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)