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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:
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01293422
First received: February 9, 2011
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: PXR-aktivaation Vaikutukset Sokeri-, Kolesteroli- ja Hormonitasapainoon

Resource links provided by NLM:

Drug Information available for: Rifampin
U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Glucose levels during oral glucose tolerance test [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01293422     History of Changes
Other Study ID Numbers: Rifa-2, 2010-023662-47
Study First Received: February 9, 2011
Last Updated: September 7, 2012
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013