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A Study To Investigate The Effect Of Erythromycin On The Pharmacokinetics Of PH-797804

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01589614
First received: April 30, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.


Condition Intervention Phase
Healthy
Drug: PH-797804
Drug: PH-797804 + erythromycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Randomised, Open Label, Two Sequence, Two Treatment, Two Way Crossover Study to Estimate the Steady-state Effect of Erythromycin on the Single Dose Pharmacokinetics of Ph-797804 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PH-797804 6 mg
Subjects will receive a single 6 mg dose in the fed state
Drug: PH-797804
Tablet, 6mg, single
Experimental: PH-797804 6 mg + erythromycin 800 mg
Subjects will receive multiple 800 mg doses of erythromycin and a single 6 mg dose of PH-797804 in the fed state
Drug: PH-797804 + erythromycin
PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple

  Eligibility

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

Inclusion Criteria:

  • Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 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 measurements, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week for males.
  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: NCT01589614

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01589614     History of Changes
Other Study ID Numbers: A6631036
Study First Received: April 30, 2012
Last Updated: August 16, 2012
Health Authority: Singapore: Singapore Health Sciences Authority

Additional relevant MeSH terms:
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014