A phase 1, randomized, placebo-controlled study to assess the safety and pharmacokinetics of multiple ascending dose regimens of TP-6076.
Completed
- Conditions
- Infecties.Infections.
- Registration Number
- NL-OMON45496
- Lead Sponsor
- Tetraphase Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion Criteria
Healthy male or female
18-55 years, inclusive
BMI 18.0-35.0 kilogram/meter2
Weight between 50 (female) and 60 (male) and 105 kilograms, inclusive
Non smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of multiple dose regimens of TP-6076.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine the plasma pharmacokinetic (PK) profile for TP-6076, its carbon-4<br /><br>(C-4) epimer TP-5589, and degradation products TP-2847 and TP-5031 following<br /><br>multiple doses.<br /><br>To determine the urinary excretion of TP-6076 following multiple doses.</p><br>