Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06651600 or Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02309827

JAK3 (Other Identifier)

B7981001

PF-06651600 (Other Identifier)

2014-004326-17 (EudraCT Number)

Details and patient eligibility

About

This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers.

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• Evidence of personally signed and dated informed consent document.
• Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
• Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
• Screening blood pressure >140/90 mm Hg.
• Screening laboratory abnormalities as defined by the protocol.
• Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Trial design

80 participants in 9 patient groups

Cohort 1: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 2: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 3: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 4: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 5: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 6: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 7: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 8: PF-06651600 or Placebo

Experimental group

Description:

Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo

Cohort 9: PF-06651600 or Placebo

Experimental group

Description:

Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK.

Treatment:

Drug: PF-06651600 or Placebo