Topical Multiple Ascending Dose Study for PF-06423264

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Normal Healthy

Treatments: Other: Placebo; Drug: PF-06423264

Study type: Interventional

Funder types: Industry

Identifiers

NCT02778477

2014-003736-39 (EudraCT Number)

B7561002

Details and patient eligibility

About

The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.

Enrollment: 65 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and female of non-childbearing potential;
• Body Mass Index 17.5-35.5 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)

Trial design

65 participants in 18 patient groups, including a placebo group

Part A_Cohort 1_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 1_Placebo

Placebo Comparator group

Description:

Multiple dose of placebo

Treatment:

Other: Placebo

Part A_Cohort 2_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 2_Placebo

Placebo Comparator group

Description:

Multiple dose of placebo

Treatment:

Other: Placebo

Part A_Cohort 3_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 3_Placebo

Placebo Comparator group

Description:

Multiple dose of placebo

Treatment:

Other: Placebo

Part A_Cohort 4_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 4_Placebo

Placebo Comparator group

Description:

Multiple dose of placebo

Treatment:

Other: Placebo

Part A_Cohort 5_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 5_Placebo

Placebo Comparator group

Description:

Multiple dose of placebo

Treatment:

Other: Placebo

Part A_Cohort 6_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 6_Placebo

Placebo Comparator group

Description:

Multiple dose of placebo

Treatment:

Other: Placebo

Part A_Cohort 7_Active

Experimental group

Description:

Multiple ascending dose of PF-06423264

Treatment:

Drug: PF-06423264

Part A_Cohort 7_Placebo

Placebo Comparator group

Description:

Multiple ascending dose of placebo

Treatment:

Other: Placebo

Part B_Cohort 1_Active

Experimental group

Description:

Multiple doses of PF-06423264

Treatment:

Drug: PF-06423264

Part B_Cohort 1_Placebo

Placebo Comparator group

Description:

Multiple doses of placebo

Treatment:

Other: Placebo

Part B_Cohort 2_Active

Experimental group

Description:

Multiple doses of PF-06423264

Treatment:

Drug: PF-06423264

Part B_Cohort 2_Placebo

Placebo Comparator group

Description:

Multiple doses of placebo

Treatment:

Other: Placebo