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PARP Inhibitor
Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule
Phase 1
Waitlist Available
Research Sponsored by Tesaro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years 5 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new tablet form of niraparib compared to the current capsule form. The effects of a high-fat meal on niraparib are also being evaluated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years 5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
AUC(0-t) for Niraparib-Stage 2 PK Phase
+19 moreSecondary study objectives
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
+5 moreSide effects data
From 2023 Phase 1 trial • 236 Patients • NCT0332900111%
Nausea
10%
Constipation
8%
Fatigue
6%
Vomiting
6%
Anaemia
1%
Upper gastrointestinal haemorrhage
1%
Peripheral motor neuropathy
1%
Abdominal pain
1%
Biliary tract infection
1%
Pulmonary embolism
1%
Asthma
1%
Gastric ulcer
1%
Sepsis
1%
Hyponatraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 2: Niraparib Tablet
Stage 1: Niraparib Tablet
Extension Phase: Niraparib Capsule
Stage 3: Niraparib Tablet Fed
Stage 2: Niraparib Capsule
Stage 1: Niraparib Capsule
Extension Phase: Niraparib Tablet
Stage 3: Niraparib Tablet Fasted
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Stage 3: High fat meal-fasted sequenceExperimental Treatment1 Intervention
Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.
Group II: Stage 3: Fasted-high fat meal sequenceExperimental Treatment1 Intervention
Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.
Group III: Stage 2: Tablet-Capsule SequenceExperimental Treatment2 Interventions
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.
Group IV: Stage 2: Capsule-Tablet SequenceExperimental Treatment2 Interventions
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Group V: Stage 1: Tablet-Capsule SequenceExperimental Treatment2 Interventions
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase
Group VI: Stage 1: Capsule-Tablet SequenceExperimental Treatment2 Interventions
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib Capsule
2017
Completed Phase 1
~240
Niraparib Tablet
2017
Completed Phase 1
~240
Find a Location
Who is running the clinical trial?
Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
10,320 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,606 Previous Clinical Trials
6,145,106 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors