Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649

NCT02151617

Healthy

COMPLETED PHASE1

Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571

NCT03092232

Healthy

COMPLETED PHASE1

A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162

NCT01691274

Healthy

COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of PF-06852231 in Healthy Subjects

NCT03217604

Healthy Volunteers

COMPLETED PHASE1

Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions

NCT02224651

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1_Cohort 1_Active

Single, escalating dose of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

Single or repeated, escalating dose of PF-05221304

Part 1_Cohort 1_Placebo

Single dose of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

single or repeated dose of placebo

Part 1_Cohort 2_Active

Single, escalating dose of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

Single or repeated, escalating dose of PF-05221304

Part 1_Cohort 2_Placebo

Single dose of Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

single or repeated dose of placebo

Part 2_Active

Repeated, escalating doses of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

Single or repeated, escalating dose of PF-05221304

Part 2_Placebo

Repeated doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

single or repeated dose of placebo

Part 3

Single dose of PF-05221304 with and without food

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

Single or repeated, escalating dose of PF-05221304

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-05221304

Single or repeated, escalating dose of PF-05221304

Intervention Type DRUG

Placebo

single or repeated dose of placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes