Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845

A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856258

Enrollment

Registered

2009-03-05

Start date

2009-03-31

Completion date

2009-06-30

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Multiple dose in healthy volunteers

Brief summary

To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.

Detailed description

The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.

Interventions

DRUGPF 03882845 and Placebo

The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. * An informed consent document signed and dated by the subject or a legally acceptable representative. * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

* Evidence or history of clinically significant disease, allergy or clinical findings at screening. * A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3. * Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. * Pregnant or nursing females; females of childbearing potential.

Design outcomes

Primary

Measure	Time frame
Single Dose PK: Cmax, Tmax, and AUCtau; Multiple Dose PK (Assumed Steady State): Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd).	13 days
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, and electrocardiograms (ECGs).	13 days

Secondary

Measure	Time frame
Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10.	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026