The effects of PXR activation on HDL-cholesterol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003347-10-FI

Enrollment

Registered

2016-12-05

Start date

2017-01-16

Completion date

Unknown

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Trade Name: Rimapen Pharmaceutical Form: Tablet INN or Proposed INN: RIFAMPICIN CAS Number: 13292-46-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmace

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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. For the sub-study: week 4.	—

Measure

Time frame

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. 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. For the sub-study: week 4.

—

Secondary

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

Measure

Time frame

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

—

Countries

Finland

Contacts

Public Contactjanne.hukkanen@oulu.fi

Oulu University Hospital, Internal Medicine Research Unit

janne.hukkanen@oulu.fi35883156212

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026