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

Healthy Clinical Trial

Official title:

A Phase 1, First-Into-Human, Escalating Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-03382792 After Administration Of Single Oral Doses To Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01045863
• Other study ID #: B1651001
• Status: Terminated
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: August 3, 2010
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-03382792 Cohort 1
First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
• PF-03382792 Cohort 2
Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
• PF-03382792
Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.
• Food Effect cohort
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.
• CSF cohort
Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	No
Secondary	Plasma aldosterone concentrations.		For Part A and C; up to 24 hours post final dose	No
Secondary	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	No
Secondary	03227077 over time (eg, AUC, Cmax, Tmax).		Part C only, up to 8 hours post dose	No

External Links

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