Healthy Subjects Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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