A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06372865 or Placebo; Drug: PF-06372865 or Placebo or Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951144

B7431001

Details and patient eligibility

About

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic interaction between PF-06372865 and lorazepam will be evaluated.

Enrollment: 45 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (e.g., gastrectomy).
• A positive urine drug screen.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 4 patient groups

Cohort 1:

Experimental group

Description:

Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Treatment:

Drug: PF-06372865 or Placebo

Drug: PF-06372865 or Placebo

Drug: PF-06372865 or Placebo

Cohort 2:

Experimental group

Description:

Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Treatment:

Drug: PF-06372865 or Placebo

Drug: PF-06372865 or Placebo

Drug: PF-06372865 or Placebo

Cohort 3:

Experimental group

Description:

Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Treatment:

Drug: PF-06372865 or Placebo

Drug: PF-06372865 or Placebo

Drug: PF-06372865 or Placebo

Cohort 4 (optional cohort):

Experimental group

Description:

Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.

Treatment:

Drug: PF-06372865 or Placebo or Lorazepam