Absorption, Metabolism, Excretion, and the Determination of Absolute Bioavailability of Niraparib in Subjects With Cancer

Sponsor
Tesaro, Inc.
Study ID
NCT02476552
Phase
PHASE1
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

Study Details

This is an open-label study with 2 parts, plus an extension study following completion of Parts 1 or 2, that is being conducted in approximately 12 subjects (6 subjects in Part 1; 6 subjects in Part 2) with cancer to examine the absorption, metabolism, excretion, and absolute bioavailability of niraparib.

Key Dates

Start date
Feb 28, 2015
Status verified
Jan 2020
Primary completion
Dec 31, 2015
Completion
Jan 31, 2018

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib Oral and IV
    Single Oral dose of Niraparib capsules (unlabeled active pharmaceutical ingredient) orally and a 15-minute IV infusion of Niraparib (labeled active pharmaceutical ingredient)
  • Experimental: Niraparib Oral
    Single Oral dose of Niraparib capsules (labeled active pharmaceutical ingredient)

Primary Outcome Measure

Oral bioavailability (F) will be derived using F=AUCoral / AUCiv as a % [ Time Frame: 0 - 22 days ]

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