A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05221304; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03597217

C1171013

Details and patient eligibility

About

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.

Enrollment: 15 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
• Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lb).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 3 patient groups, including a placebo group

Cohort A_Active

Experimental group

Description:

3 single doses treatment of PF-05221304

Treatment:

Drug: PF-05221304

Drug: PF-05221304

Cohort B_Active

Experimental group

Description:

Repeated doses of PF-05221304

Treatment:

Drug: PF-05221304

Drug: PF-05221304

Cohort B_Placebo

Placebo Comparator group

Description:

Repeated doses of placebo

Treatment:

Drug: Placebo