Clinical trial NCT02871037: Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
Official title: A Phase 1, 3-part Study Of Pf-05221304 In Healthy Adults: Part 1 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Single, Escalating, Oral Doses; Part 2 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Repeated, Escalating, Oral Doses; Conditional Part 3 - Effect Of Food On The Pharmacokinetics Of Pf-05221304
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.


Eligibility criteria: Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Body Mass Index 17.5-30.5 kg/m2;
* Body weight \>50 kg;

Exclusion Criteria:

* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing

Primary outcomes:
measure: Part 1: Number of Subjects experiencing an Adverse Event
timeFrame: Screening up to 28 days after last dose of study medication
measure: Part 2: Number of Subjects experiencing an Adverse Event
timeFrame: Screening up to 28 days after last dose of study medication
measure: Part 3: Maximum Observed Plasma Concentration (Cmax) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 3: Time to Reach Maximum Observed Concentration for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 3: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 3: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 3: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 3: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
Secondary outcomes:
measure: Part 1:Maximum Observed Plasma Concentration (Cmax) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: Time to Reach Maximum Observed Concentration for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: dose-normalized Cmax and AUClast for PF05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: Apparent Total Body Clearance (CL/F) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 1: Apparent Volume of Distribution (Vz/F) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16, 24, 36, and 48 hours post dose
measure: Part 2: Single dose plasma parameters of Cmax for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
measure: Part 2: Single-dose plasma parameters of Tmax for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
measure: Part 2: Single-dose plasma parameters of Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose on Day 1
measure: Part 2: Multiple-dose plasma parameters of Cmax for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of Tmax for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of AUCtau for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of Minimum Observed Plasma Trough Concentration (Cmin) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of CL/F for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of Vz/F for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose
measure: Part 2: Multiple-dose plasma parameters of Peak-trough ratio (PTR) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of Observed accumulation ratio for Cmax (Rac(Cmax)) for PF-05221304
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of Observed accumulation ratio (Rac(AUCtau))
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post dose for Day 7; (and Day 14, as permitted)
measure: Part 2: Multiple-dose plasma parameters of Plasma Decay Half-Life (t1/2) for PF-05221304 (as permitted)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours on Day 1 and 7, and 0 hr on Day 2, Day 4, Day 8, Day 10, Day 13, Day 15, and Day 16 post dose
measure: Part 3: Number of Subjects experiencing an Adverse Event
timeFrame: Screening up to 28 days after last dose of study medication
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: