PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers

NCT02553356 | Completed Phase 1

• 1 other identifier: PT2385-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Female Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety and tolerability of PT2385 Tablets in normal healthy adult subjects by reviewing the incidence of treatment-emergent adverse events.

  30 days

• Pharmacodynamic (PD) effects of treatment with PT2385 Tablets (plasma levels).

  6 days

Study Arms (2)

Fasted

EXPERIMENTAL

PT2385 taken after fasting.

Drug: PT2385

Non-Fasting

EXPERIMENTAL

PT2385 taken after eating a high calorie meal.

Drug: PT2385

Interventions

PT2385 DRUG

Fasted; Non-Fasting

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, United States

Location

MeSH Terms

Interventions

PT2385

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

US (1)