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

Healthy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PF-06372865 or PlaceboPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.

Drug:PF-06372865 or PlaceboPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.

Drug:PF-06372865 or PlaceboPF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.

Drug:PF-06372865 or Placebo or LorazepamLorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Cohort 1:Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Cohort 2:Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Cohort 3:Single ascending doses of PF-06372865 or placebo to investigate the safety/tolerability PK and PD of PF-06372865.

Cohort 4 (optional cohort):Two single doses of PF-06372865 or placebo or lorazepam to further investigate the pharmacodynamics of PF-06372865.

Study Status

Completed

Start Date: October 2013

Completed Date: July 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Maximum Observed Plasma Concentration (Cmax)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Pfizer CT.gov Call Center

Lead Sponsor: Pfizer

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01951144

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