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PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Peloton Therapeutics, Inc. Identifier:
First received: September 11, 2015
Last updated: December 8, 2015
Last verified: December 2015
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.

Condition Intervention Phase
Healthy Drug: PT2385 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2385 Tablets

Further study details as provided by Peloton Therapeutics, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 16
Study Start Date: September 2015
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasted
PT2385 taken after fasting.
Drug: PT2385
Experimental: Non-Fasting
PT2385 taken after eating a high calorie meal.
Drug: PT2385

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02553356

United States, Wisconsin
Spaulding Clinical
West Bend, Wisconsin, United States
Sponsors and Collaborators
Peloton Therapeutics, Inc.
  More Information

Responsible Party: Peloton Therapeutics, Inc. Identifier: NCT02553356     History of Changes
Other Study ID Numbers: PT2385-102
Study First Received: September 11, 2015
Last Updated: December 8, 2015

Keywords provided by Peloton Therapeutics, Inc.:
Female Subjects processed this record on June 23, 2017