CClinicalTrials.gg
CompletedNCT00369304Updated Aug 7, 2009

Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate

A Phase 1 interventional study of pharmacokinetic (how the body absorbs and eliminates) interaction in Healthy Subjects, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Health
03

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  1. Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
  2. Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
  3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
  4. Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
  5. Have a high probability for compliance with and completion of the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)

Interventions

  • Drugpharmacokinetic (how the body absorbs and eliminates) interaction
06

What researchers measure

Primary outcomes

  1. To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00369304
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Aug 29, 2006
Start date
Jul 2006
Primary completion
Aug 2006
Completion
Aug 2006
Last update
Aug 7, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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