A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Pfizer

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 serial blood sample (4 ml) each was collected at predose on day 27 of period 1 and day 20 of periods 2, predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on day 28 of period 1 and day 21 of period 2 to 3, respectively.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a cancer drug called talazoparib in two forms: a pill and a new liquid-filled capsule. It targets patients with advanced solid tumors and works by preventing cancer cells from repairing their DNA.

Eligible Conditions

Breast Cancer
Ovarian Cancer
Prostate Cancer
Solid Tumors
Non-Small Cell Lung Cancer
Pancreatic Cancer
Colorectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ serial blood sample (4 ml) each was collected at predose on day 27 of period 1 and day 20 of periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on day 28 of period 1 and day 21 of period 2 to 3, respectively.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~serial blood sample (4 ml) each was collected at predose on day 27 of period 1 and day 20 of periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on day 28 of period 1 and day 21 of period 2 to 3, respectively.

This trial's timeline: 3 weeks for screening, Varies for treatment, and serial blood sample (4 ml) each was collected at predose on day 27 of period 1 and day 20 of periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on day 28 of period 1 and day 21 of period 2 to 3, respectively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions

Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions

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Secondary study objectives

Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing

Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities)

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