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Effects of Pregnane X Receptor (PXR) Activation on Human Glucose, Lipid and Hormone Homeostasis (Rifa-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293422
First Posted: February 10, 2011
Last Update Posted: September 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Oulu
  Purpose
This clinical trial is designed to study the effects of pregnane X receptor activator rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin raises postprandial glucose studied with oral glucose tolerance test. The study is a non-randomized, one-phase, open-label trial. Twelve subjects will be given 600 mg of rifampicin a day for a week. The main outcome measures are the changes in the glucose and insulin levels during oral glucose tolerance test.

Condition Intervention Phase
Glucose Metabolism Drug: Rifampicin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: PXR-aktivaation Vaikutukset Sokeri-, Kolesteroli- ja Hormonitasapainoon

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Glucose levels during oral glucose tolerance test

Enrollment: 12
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifampicin Drug: Rifampicin
Rifampicin 600 mg daily for a week
Other Name: Rimapen, ATC J04AB02

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer
  • Age 18-45 years
  • Body mass index 19-28

Exclusion Criteria:

  • Any continuous medication
  • Any significant disease
  • Allergy to rifampicin
  • Pregnancy and breast feeding
  • Fear of needles and previous difficult blood samplings
  • Substance abuse
  • Participation in another clinical drug trial within 1 month of enrollment
  • Use of soft contact lenses
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293422


Locations
Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Janne Hukkanen, MD, PhD Oulu University Hospital
  More Information

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01293422     History of Changes
Other Study ID Numbers: Rifa-2
2010-023662-47 ( EudraCT Number )
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by University of Oulu:
PXR, glucose, cholesterol

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers