PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers

Study Overview
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Brief Summary
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This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of PT2385 Tablets. The study will consist of two periods and will be conducted in a crossover fashion.

Detailed Description
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Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected for after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.

Official Title
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A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2385 Tablets

Conditions
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Healthy

Intervention / Treatment
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* Drug: PT2385


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female between 18 and 45 years of age; If of childbearing potential, willing to practice methods of birth control; If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial; Has a body mass index (BMI) between 19 and 32 kg/m2; Willing and able to give written informed consent for study participation and provide consent for access to medical data; Willing and able to cooperate with all aspects of the protocol. Exclusion Criteria: Any vaccination within 30 days before start of this study and throughout the study; Use of or need for any systemic drug(s) including vitamins or herbal preparations other than drugs used for contraception, within 30 days before entry into the study or during the study; Use of aspirin, non-steroidal anti-inflammatory agents, or acetaminophen within 5 days prior to the ingestion of the study drug; Donation or receipt of blood or blood components within the 4 weeks prior to the start of the study; Any diagnostic or intervention procedure requiring a contrast agent within the 30 days prior to the start of study participation; Abnormal blood pressure or pulse rate; Abnormal screening electrocardiogram (ECG); Use of tobacco or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.); Consumption of alcohol or xanthine-containing products; Consumption of grapefruit, star fruit, Seville oranges, or products containing any of these ingredients; Receipt of any investigational agent within 30 days; A positive history of drug abuse or a positive test result for drug(s) of abuse; Female subjects who are planning a pregnancy or are pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted<br>PT2385 taken after fasting. | Drug: PT2385<br> <br> |
| Experimental: Non-Fasting<br>PT2385 taken after eating a high calorie meal. | Drug: PT2385<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of food on the pharmacokinetics of a single dose of PT2385 Tablets administered to normal healthy adult subjects (Cmax). | Peak Plasma Concentration (Cmax) will be assessed in both the fasting and non-fasting conditions and compared. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of PT2385 Tablets in normal healthy adult subjects by reviewing the incidence of treatment-emergent adverse events. | Analyses will consist of data summaries for AEs/SAEs | 30 days | 
| Pharmacodynamic (PD) effects of treatment with PT2385 Tablets (plasma levels). | Variability in biomarkers will be correlated with plasma levels of PT2385. | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female Subjects