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A Study to Assess the Effects of Multiple Doses of Fidaxomicin on a Single Dose of Rosuvastatin in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02083627
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : May 21, 2014
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

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.

Condition or disease Intervention/treatment Phase
Drug-Drug Interaction (DDI) Intestinal Absorption Healthy Subjects Pharmacokinetics of Rosuvastatin Pharmacokinetics of Fidaxomicin Drug: rosuvastatin Drug: fidaxomicin Phase 1

Detailed Description:

Sequence 1:

Thirteen subjects receive an oral dose of rosuvastatin on Day 1 in Period 1 and on Day 13 in Period 2 and twice-daily oral doses of fidaxomicin on Days 8 to 17 in Period 2, according to the following treatment schedule:

  • Period 1: Subjects receive a single oral dose of rosuvastatin on Day 1, followed by a 5-day pharmacokinetic (PK) sampling period.
  • Period 2: The same subjects receive fidaxomicin twice daily for 5 days (Days 8 to 12). On Day 13, a single oral dose of rosuvastatin and an oral dose of fidaxomicin is administered simultaneously in the morning. Twice-daily treatment with fidaxomicin continues until the end of Day 17. Subjects are discharged on Day 18 when all assessments are performed and if there are no medical reasons to prolong the stay.

Sequence 2:

Thirteen subjects receive an oral dose of rosuvastatin on Day 6 in Period 1 and on Day 14 in Period 2. Oral doses of fidaxomicin are administered twice daily for 10 days in Period 1, according to the following treatment schedule:

  • Period 1: Subjects receive fidaxomicin twice daily for 5 days (Days 1 to 5). On Day 6, a single oral dose of rosuvastatin is administered simultaneously with an oral dose of fidaxomicin in the morning. Twice daily treatment with fidaxomicin continues until the end of Day 10.
  • Period 2: Subjects receive a single oral dose of rosuvastatin on Day 14, followed by a 5-day PK sampling period. Subjects are discharged on Day 19 when all assessments are performed and if there are no medical reasons to prolong the stay.

In both sequences, subjects return to the clinical unit for an End of Study Visit (ESV) 7 to 14 days after (early) discharge.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open Label, Randomized, Two-way Crossover Study to Evaluate the Effect of Multiple Doses of Fidaxomicin on the Single Dose Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1:Single rosuvastatin,multiple fidaxomicin,single rosuvastatin Drug: rosuvastatin
Oral
Other Name: Crestor®

Drug: fidaxomicin
Oral
Other Names:
  • Dificlir™
  • DIFICID®

Experimental: 2:Multiple fidaxomicin,single rosuvastatin,single rosuvastatin Drug: rosuvastatin
Oral
Other Name: Crestor®

Drug: fidaxomicin
Oral
Other Names:
  • Dificlir™
  • DIFICID®




Primary Outcome Measures :
  1. Effect of multiple doses of fidaxomicin on the single dose pharmacokinetics of rosuvastatin as measured by maximum observed concentration [ Time Frame: Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2) ]
    Cmax (maximum observed concentration)

  2. 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 [ Time Frame: Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2) ]
    AUCinf (area under the concentration time curve from time zero extrapolated to infinity)


Secondary Outcome Measures :
  1. Effect of multiple doses of fidaxomicin on the single dose pharmacokinetic profile of rosuvastatin [ Time Frame: Day 1-6 (sequence1/period1) & Day 13-18 (sequence1/period2) Day 6-11 (sequence2/period1) & Day 14-19 (sequence2/period2) ]
    AUClast (Area under the concentration time curve from time point zero to last quantifiable concentration), CL/F (apparent clearance following oral administration), tmax (time to attain Cmax (maximum observed concentration), t1/2 (terminal elimination half-life), Vz/F (apparent volume of distribution during terminal phase)

  2. Safety and tolerability of multiple doses of fidaxomicin in the presence of a single dose of rosuvastatin [ Time Frame: Screening (Day -22 to -2) to ESV (7 to 14 days after (early) discharge) ]
    Adverse Events (AE), vital signs, laboratory tests, 12-lead Electrocardiogram (ECG)

  3. PK of multiple doses of fidaxomicin and its metabolite OP-1118 [ Time Frame: Day 9-15 (sequence 1/period2) & Day 2-8 (sequence2/period1) ]
    tmax (time to attain Cmax (maximum observed concentration), AUCtau (area under the concentration time curve over a dosing interval), Ctrough (measured concentration at the end of a dosing interval (taken directly before next administration))



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083627


Locations
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Germany
Parexel GmbH
Berlin, Germany, D-14059
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Cubist Pharmaceuticals LLC
Investigators
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Study Director: Medical Monitor Astellas Pharma Europe B.V.
Additional Information:
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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02083627    
Other Study ID Numbers: 2819-CL-2003
2012-003924-20 ( EudraCT Number )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Pharmacokinetics
Drug-Drug Interaction
Intestinal Absorption
Fidaxomicin
Rosuvastatin
Multiple Doses
Single Doses
Additional relevant MeSH terms:
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Fidaxomicin
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents