The effects of PXR activation on HDL-cholesterol

Phase 1

Conditions: Healthy volunteers
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2016-003347-10-FI

Lead Sponsor: Oulu University Hospital, Internal Medicine Research Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

Healthy volunteers
18-40 years of age
Body mass index (BMI) 18.5-30 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Systolic pressure more than 150 mmHg
Any continuous medication (including birth control pills; hormonal intrauterine device, inhaled asthma medications, and topical treatments for skin diseases are permitted)
Any significant medical condition including any liver disease
Insensitivity to rifampicin
Pregnancy and breast feeding
History of difficult venipuncture
Alcohol and medicine abuse and drug use
Participation in any other pharmaceutical trial within one month of screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study how PXR activation by rifampicin affects HDL cholesterol metabolism;Secondary Objective: To study how PXR activation by rifampicin affects glucose metabolism and blood pressure regulation.;Primary end point(s): Percent change of HDL2 fraction between baseline and week 4 compared across placebo and rifampicin arms.<br>For the sub-study: difference between rifampicin and placebo arms in the duodenal expression of cholesterol transporters.;Timepoint(s) of evaluation of this end point: Baseline, week 4.<br>For the sub-study: week 4.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: a) Week 4.<br>b) Week 4.<br>c) Baseline, week 4, 6, and 8.<br>d) Week 4 and 6.<br>e) At various timepoints during study.<br>f) Baseline and week 4.5.<br>g) Week 2 and week 4.5.;Secondary end point(s): a) Difference between rifampicin and placebo arms in glucose, insulin and glucagon AUCs of oral glucose tolerance test.<br>b) Sex difference between rifampicin and placebo arms in glucagon AUCs of oral glucose tolerance test.<br>c) Percent change of cholesterol fractions other than HDL2 between rifampicin and placebo arms.<br>d) Difference between rifampicin and placebo arms in fecal cholesterol fractions and bile acids.<br>e) Difference between rifampicin and placebo arms in office blood pressure, plasma renin activity, aldosterone and angiotensin II.<br>f) Percent change of flow-mediated dilatation and heart rate variability.<br>g) Difference between rifampicin and placebo arms in day-urine metanephrine, normetanephrine, and aldosterone excretion.