Recruitment

Recruitment Status
Completed

Inclusion Criterias

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.
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.
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.

Exclusion Criterias

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

Summary

Conditions
  • Drug-Drug Interaction (DDI)
  • Healthy Subjects
  • Intestinal Absorption
  • Pharmacokinetics of Fidaxomicin
  • Pharmacokinetics of Rosuvastatin
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 55 years
Gender
Only males

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...

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.

Inclusion Criterias

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.
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.
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.

Exclusion Criterias

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

Locations

Berlin, D-14059
Berlin, D-14059

Tracking Information

NCT #
NCT02083627
Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Medical Monitor Astellas Pharma Europe B.V.