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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01589614

Enrollment

Registered

2012-05-02

Start date

2012-06-30

Completion date

2012-08-31

Last updated

2012-08-17

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

Conditions

Healthy

Brief summary

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.

Interventions

DRUGPH-797804

Tablet, 6mg, single

DRUGPH-797804 + erythromycin

PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Maximum Observed Plasma Concentration (Cmax)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Plasma Decay Half-Life (t1/2)	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]	0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose

Countries

Singapore

Outcome results

None listed

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