NCT02083627

Brief Summary

This study will assess the effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin in healthy male subjects. Determine the safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin in healthy male subjects. Also determine the pharmacokinetics of multiple doses of fidaxomicin and its metabolite OP-1118.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

28 days

First QC Date

March 7, 2014

Last Update Submit

May 19, 2014

Conditions

Drug-Drug Interaction (DDI)Intestinal AbsorptionHealthy SubjectsPharmacokinetics of RosuvastatinPharmacokinetics of Fidaxomicin

Keywords

PharmacokineticsDrug-Drug InteractionIntestinal AbsorptionFidaxomicinRosuvastatinMultiple DosesSingle Doses

Outcome Measures

Primary Outcomes (2)

  • Effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin as measured by maximum observed concentration

    Cmax (maximum observed concentration)

    Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2)

  • Effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin as measured by area under the concentration time curve from time zero extrapolated to infinity

    AUCinf (area under the concentration time curve from time zero extrapolated to infinity)

    Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2)

Secondary Outcomes (3)

  • Effect of multiple doses of fidaxomicin on the single dose pharmacokinetic profile of rosuvastatin

    Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2)

  • Safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin

    Screening (Day -22 to -2) to ESV (7 to 14 days after (early) discharge)

  • PK of multiple doses of fidaxomicin and its metabolite OP-1118

    Day 9-15 (sequence 1/period2) & Day 2-8 (sequence2/period1)

Study Arms (2)

1:Single rosuvastatin,multiple fidaxomicin,single rosuvastatin

EXPERIMENTAL
Drug: rosuvastatinDrug: fidaxomicin

2:Multiple fidaxomicin,single rosuvastatin,single rosuvastatin

EXPERIMENTAL
Drug: rosuvastatinDrug: fidaxomicin

Interventions

rosuvastatinDRUG

Oral

Also known as: Crestor®
1:Single rosuvastatin,multiple fidaxomicin,single rosuvastatin2:Multiple fidaxomicin,single rosuvastatin,single rosuvastatin
fidaxomicinDRUG

Oral

Also known as: Dificlir™, DIFICID®
1:Single rosuvastatin,multiple fidaxomicin,single rosuvastatin2:Multiple fidaxomicin,single rosuvastatin,single rosuvastatin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The subject has a Body Mass Index (BMI) range of 18.5 to 30.0 kg/m2. The subject weighs at least 50 kg at Screening.
  • Male subject and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period and for 90 days after final study drug administration.
  • The subject must not donate sperm starting at Screening and through-out the study period and for at least 90 days after final study drug administration.

You may not qualify if:

  • The subject has a history of or current Clostridium difficile infection.
  • The subject has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
  • The subject has an irregular defecation pattern.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel GmbH

Berlin, D-14059, Germany

Location

MeSH Terms

Interventions

Rosuvastatin CalciumFidaxomicin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrolidesLactonesPolyketidesMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

February 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

DE(1)