Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects

November 28, 2016 updated by: PharmAkea, Inc.

A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects

A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS2 9LH
        • Covance Clinical Research Unit Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
  • body weight of 50 to 100 kg, inclusive
  • subjects must be in good health

Exclusion Criteria:

  • male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
  • female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
  • history of, any clinically significant major disorder
  • clinically significant allergic condition
  • significant history of alcoholism or drug/chemical abuse
  • use of any tobacco or nicotine-containing products
  • clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
  • positive urine drugs of abuse screen or alcohol breath test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAT-1251 Single Dose
Oral solution of PAT-1251, 150 - 4000 mg administered once
Drug: PAT-1251
Placebo Comparator: Placebo Single Dose
Matching placebo solution administered once
Drug: Placebo
Experimental: PAT-1251 Multiple Dose
Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
Drug: PAT-1251
Experimental: Placebo Multiple Dose
Matching placebo tablets administered daily for 7 days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: one to seven days
Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination
one to seven days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: one to seven days
one to seven days
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time Frame: one to seven days
one to seven days
Time to Maximum Observed Plasma Concentration (Tmax)
Time Frame: one to seven days
Comparative pharmacokinetics of single dose administered in a fasted state and following a meal
one to seven days
Terminal elimination half-life (t½)
Time Frame: one to seven days
one to seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmAkea, Inc.

Investigators

  • Study Director: Kevin Holme, Ph.D., PharmAkea, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimate)

August 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 30, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • PAT-1251-CL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe