Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib

Sponsor
pharmaand GmbH
Study ID
NCT02986100
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • C-14 labeled Rucaparib — DRUG
    Each dosage unit consists of a hard gelatin capsule filled with cold rucaparib camsylate and \[14C\]-rucaparib camsylate salt. Each capsule contains approximately 150 mg rucaparib (free base weight) and approximately 35 µCi of \[14C\]-rucaparib. Each patient will ingest four capsules in the fasted state for a total dose of 600 mg rucaparib (free base weight) with approximately 140 µCi of \[14C\]-rucaparib
  • Rucaparib — DRUG
    200 \& 300 mg tablet

Study Details

The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered \[14C\] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation

Key Dates

Start date
Nov 30, 2016
Status verified
Jun 2023
Primary completion
Dec 31, 2017
Completion
Sep 30, 2018

Study Design

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

Arms

  • Experimental: C-14 labeled rucaparib
    Each patient will receive a single oral dose of 600 mg \[14C\] rucaparib (approximately 140 µCi) in the fasted state. Patients will be confined at the study site for the collection of blood samples and excreta for a maximum of 13 days, from Day -1. The patient can be discharged sooner than Day 13, if the discharge criteria are met. After completion of Part I, patients with a deleterious BRCA mutation will have the option to participate in Part II by receiving 600 mg BID rucaparib tablets orally in 28 day cycles until disease progression, unacceptable toxicity, death, or discontinuation for other reasons

Primary Outcome Measure

Pharmacokinetics of 14C-labeled rucaparib (radioactivity in whole blood and plasma): tmax [ Time Frame: Days 1-13 ]

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