Study To Evaluate The Effect Of A Multiple Oral Dose Of PF-00232798 On QT Intervals In Healthy Subjects

This study has been completed.
ViiV Healthcare
Information provided by:
Pfizer Identifier:
First received: June 7, 2010
Last updated: December 22, 2010
Last verified: December 2010

The purpose of this study is to assess the affect that PF-00232798 has on QT interval. A prolonged QT interval is a risk factor for arrhythmias.

Condition Intervention Phase
Drug: PF-00232798
Drug: Placebo
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Multiple Dose, Placebo And Active Controlled, 4-Way Crossover Study To Evaluate The Effect Of A Multiple Oral Dose of PF-00232798 On Qt Intervals In Healthy Subjects

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin on Day 7 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • QTcB or any other appropriate correction method at each postdose time point of PF-00232798 and placebo on Day 7 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic endpoints for PF-00232798 (Tmax, Cmax, Cτ, and AUClast) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00232798 supratherapeutic dose
PF-00232798 supratherapeutic dose
Drug: PF-00232798
600 mg oral solution once daily x 7 days
Experimental: PF-00232798 therapeutic dose
PF-00232798 therapeutic dose
Drug: PF-00232798
300 mg oral solution once daily x 7 days
Placebo Comparator: Placebo for PF-00232798
Placebo for PF-00232798
Drug: Placebo
Oral solution once daily x 7 days
Active Comparator: Moxifloxacin
Drug: Moxifloxacin
400 mg tablet single dose


Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
  • 12-lead ECG demonstrating QTc >450 msec at screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • History of orthostatic symptoms or orthostatic hypotension at screening.
  • Pregnant or nursing females; females of childbearing potential.
  Contacts and Locations
Please refer to this study by its identifier: NCT01140425

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
ViiV Healthcare
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01140425     History of Changes
Other Study ID Numbers: A7691017
Study First Received: June 7, 2010
Last Updated: December 22, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 17, 2014