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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: PF-03382792 Cohort 1; Drug: Food Effect cohort; Drug: CSF cohort; Drug: PF-03382792 Cohort 2; Drug: PF-03382792

• Registration Number: NCT01045863
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Study Start: 2010-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-03
• Last Update Posted: 2010-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PART A: Ascending Cohorts	PF-03382792 Cohort 1	Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)
PART A: Ascending Cohorts	PF-03382792 Cohort 2	Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)
PART B: Food effect	Food Effect cohort	Food effect on PF-03382792 PK
PART C: CSF Cohort	CSF cohort	Optional CSF Cohort
PART A: Ascending Cohorts	PF-03382792	Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)

Primary Outcome Measures

Name	Time	Method
Additional Safety endpoints: clinical safety laboratory endpoints, plasma cortisol and ACTH, clinical examinations, slit lamp examination.	For cohorts in Part A, up to 24 days; for Cohorts in Part B, up to 17; for Part C, up to 10 days
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).	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).	up to 72 hours post the final dose for each cohort

Secondary Outcome Measures

Name	Time	Method
Plasma aldosterone concentrations.	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	Part C only, up to 8 hours post dose
03227077 over time (eg, AUC, Cmax, Tmax).	Part C only, up to 8 hours post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States