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

This study has been completed.
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01140425
First received: June 7, 2010
Last updated: December 22, 2010
Last verified: December 2010
  Purpose

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
Healthy
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
Moxifloxacin
Drug: Moxifloxacin
400 mg tablet single dose

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140425

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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:
PF-00232798
CCR5
QT
QTc
pharmacokinetics

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014