To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01045863
First received: January 8, 2010
Last updated: August 3, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: PF-03382792 Cohort 1 Drug: PF-03382792 Cohort 2 Drug: PF-03382792 Drug: Food Effect cohort Drug: CSF cohort |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| 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 |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma aldosterone concentrations. [ Time Frame: For Part A and C; up to 24 hours post final dose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 03227077 over time (eg, AUC, Cmax, Tmax). [ Time Frame: Part C only, up to 8 hours post dose ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PART A: Ascending Cohorts
Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)
|
Drug: PF-03382792 Cohort 1
First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
Drug: PF-03382792 Cohort 2
Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.
Drug: PF-03382792
Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.
|
|
Experimental: PART B: Food effect
Food effect on PF-03382792 PK
|
Drug: 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.
|
|
Experimental: PART C: CSF Cohort
Optional CSF Cohort
|
Drug: CSF cohort
Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01045863 History of Changes |
| Other Study ID Numbers: | B1651001 |
| Study First Received: | January 8, 2010 |
| Last Updated: | August 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
volunteer |
ClinicalTrials.gov processed this record on May 16, 2013