To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers

Phase 1TerminatedNCT01045863

Pfizer10 enrolled

Overview

The purpose of this study is to evaluate safety and tolerability after a single administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and biological activity.

Evaluate the safety, tolerability, plasma concentrations of PF-03382792 and other biological activity following a single dose of PF-03382792. Three ascending single doses of PF-03382792 were administered in this study (0.05 mg, 0.15mg and 0.5 mg). The decision to terminate the study was made on June 4, 2010 due to safety findings and limitations regarding the levels of the metabolite projected for doses above 0.5 mg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-03382792 Cohort 1DRUG

First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.

PF-03382792 Cohort 2DRUG

Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.

PF-03382792DRUG

Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening. * Signs or symptoms of adrenal insufficiency. * Ocular lens (eye) abnormalities.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Safety endpoints include evaluation: adverse events, change from baseline in vital signs, triplicate ECG (Part A only), singlet ECG for Parts B and C. 8 hours of cardiac telemetry postdose (Part A only).

Time frame: For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days

Additional Safety endpoints: clinical safety laboratory endpoints, plasma cortisol and ACTH, clinical examinations, slit lamp examination.

Time frame: For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days

Pharmacokinetic endpoints: plasma concentration of PF 03382792 over time (eg, AUC, Cmax, Tmax, t1/2), plasma concentration of PF 03227077 over time (eg, AUC, Cmax, Tmax, t1/2).

Time frame: up to 72 hours post the final dose for each cohort

Secondary Outcomes

Plasma aldosterone concentrations.

Time frame: For Part A and C; up to 24 hours post final dose

Change and percent change from baseline in average CSF sAPP fragment concentrations over all postdose collection time points up to 8 hours. • CSF sAPP fragment concentrations over time. • CSF concentration of PF 03382792 and PF

Time frame: Part C only, up to 8 hours post dose

03227077 over time (eg, AUC, Cmax, Tmax).

Time frame: Part C only, up to 8 hours post dose

Data from ClinicalTrials.gov

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