Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
University of Oulu Identifier:
First received: February 9, 2011
Last updated: September 7, 2012
Last verified: September 2012

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:

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


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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 identifier: NCT01293422

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

No publications provided

Responsible Party: University of Oulu 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 processed this record on February 27, 2015