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

NCT01045863 | Terminated Phase 1

• 1 other identifier: B1651001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

volunteer

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• 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

Study Arms (3)

PART A: Ascending Cohorts

EXPERIMENTAL

Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)

Drug: PF-03382792 Cohort 1; Drug: PF-03382792 Cohort 2; Drug: PF-03382792

PART B: Food effect

EXPERIMENTAL

Food effect on PF-03382792 PK

Drug: Food Effect cohort

PART C: CSF Cohort

EXPERIMENTAL

Optional CSF Cohort

Drug: CSF cohort

Interventions

PF-03382792 Cohort 1 DRUG

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

PART A: Ascending Cohorts

PF-03382792 Cohort 2 DRUG

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

PART A: Ascending Cohorts

PF-03382792 DRUG

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

PART A: Ascending Cohorts

Food Effect cohort DRUG

Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion.

PART B: Food effect

CSF cohort DRUG

Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.

PART C: CSF Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 4, 2010

Record last verified: 2010-08

Locations

US (1)