A Phase 1 interventional study of TR-701 di-sodium phosphate salt and TR-701 free acid phosphate in Healthy, sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 1, Interventional, and Basic science
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.
Subjects will receive the following treatments in a crossover design:
Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;
Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;
Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t, and AUC0-inf.
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 18 studies on the registry; none are open to participants now.
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Exclusion Criteria:
TR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)
Drug: TR-701 free acid phosphate
One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
Drug: TR-701 di-sodium phosphate salt
One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects
Time frame: 4 days
To determine the safety and tolerability of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult
Time frame: 4 days
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)