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Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

NCT03954366 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-06-08

No results posted yet for this study

Summary

This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.

Conditions

  • Neoplasms

Interventions

DRUG

Rucaparib

Rucaparib 600 mg BID commencing on Day 5 until Day 23.

DRUG

Rosuvastatin

Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.

DRUG

Oral Contraceptives

Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

Sponsors & Collaborators

  • pharmaand GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2019-12-06
Completion
2021-06-09

Countries

  • Hungary
  • Poland
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03954366 on ClinicalTrials.gov