HealthyPhase 1NCT02553356

PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers

A Phase 1 study testing PT2385 in people with Healthy, run by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PT2385
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Dec 2015
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Clinical
West Bend, Wisconsin

Other trials in United States

About this study

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

Read the 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.

Conditions: Healthy
Being tested: PT2385
Keywords: Female Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PT2385Drug

Study groups in NCT02553356
Study group	Role	What they receive
Fasted	Experimental	PT2385 taken after fasting. Receives: Drug: PT2385
Non-Fasting	Experimental	PT2385 taken after eating a high calorie meal. Receives: Drug: PT2385

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Analyses will consist of data summaries for AEs/SAEs
Measured: 30 days
Pharmacodynamic (PD) effects of treatment with PT2385 Tablets (plasma levels).
Variability in biomarkers will be correlated with plasma levels of PT2385.
Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Dec 2015

First posted17 Sep 2015 (estimated)
Study startSep 2015
Primary completionNov 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02553356
Sponsor's protocol ID: PT2385-102
Status last verified: Dec 2015
First submitted: 11 Sep 2015
Last updated: 10 Dec 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2385 Tablets
ClinicalTrials.gov ID: NCT02553356
Acronym / sponsor ID: PT2385-102
Conditions: Healthy
Keywords: Female Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Nov 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 17 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasted	Experimental	Drug: PT2385PT2385 taken after fasting.
Non-Fasting	Experimental	Drug: PT2385PT2385 taken after eating a high calorie meal.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PT2385	Drug	Fasted, Non-Fasting

Primary outcome

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.

2 secondary outcomes

Safety and tolerability of PT2385 Tablets in normal healthy adult subjects by reviewing the incidence of treatment-emergent adverse events.
Time frame: 30 days
Pharmacodynamic (PD) effects of treatment with PT2385 Tablets (plasma levels).
Time frame: 6 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PT2385 in people with Healthy, run by Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of food on the pharmacokinetics of a single dose of PT2385 Tablets administered to normal healthy adult subjects (Cmax). (time frame: 6 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02553356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.