Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Sponsor
pharmaand GmbH
Study ID
NCT02740712
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Caffeine — DRUG
    200 mg (4 x 50mg) Tablet
  • Warfarin — DRUG
    10 mg (2 x 5mg) Tablet
  • Omeprazole — DRUG
    40 mg Tablet
  • Midazolam — DRUG
    5 mg/mL
  • digoxin — DRUG
    .25 mg Tablet
  • Vitamin K — DRUG
    10 mg Tablet
  • Rucaparib — DRUG
    200 \& 300 mg tablet

Study Details

The purpose of this study is to assess pharmacokinetic concentrations of multiple probes alone followed by assessment of the same drug pharmacokinetic concentrations when the patient has steady-state exposure to rucaparib followed by cycle-by-cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation.

Key Dates

Start date
Apr 30, 2016
Status verified
Jun 2023
Primary completion
Mar 31, 2017
Completion
Sep 30, 2019

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: single arm probe drugs and rucaparib
    Caffeine Warfarin Vitamin K Omeprazole Midazolam Digoxin rucaparib

Primary Outcome Measure

PK parameters for caffeine, S-warfarin, omeprazole, midazolam, and digoxin with and without rucaparib treatment to be calculated from the plasma concentration-time data [ Time Frame: Days 1-5 and Days 12-16 ]

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