PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02553356|
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : December 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: PT2385||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2385 Tablets|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||December 2015|
PT2385 taken after fasting.
PT2385 taken after eating a high calorie meal.
- Effect of food on the pharmacokinetics of a single dose of PT2385 Tablets administered to normal healthy adult subjects (Cmax). [ Time Frame: 6 days ]Peak Plasma Concentration (Cmax) will be assessed in both the fasting and non-fasting conditions and compared.
- Safety and tolerability of PT2385 Tablets in normal healthy adult subjects by reviewing the incidence of treatment-emergent adverse events. [ Time Frame: 30 days ]Analyses will consist of data summaries for AEs/SAEs
- Pharmacodynamic (PD) effects of treatment with PT2385 Tablets (plasma levels). [ Time Frame: 6 days ]Variability in biomarkers will be correlated with plasma levels of PT2385.
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): NCT02553356
|United States, Wisconsin|
|West Bend, Wisconsin, United States|