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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852551
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
PharmAkea, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: PAT-1251 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : July 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: one to seven days ]
  2. Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: one to seven days ]
  3. 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

  4. Terminal elimination half-life (t½) [ Time Frame: one to seven days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852551


Locations
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United Kingdom
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
PharmAkea, Inc.
Investigators
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Study Director: Kevin Holme, Ph.D. PharmAkea, Inc.
Additional Information:
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Responsible Party: PharmAkea, Inc.
ClinicalTrials.gov Identifier: NCT02852551    
Other Study ID Numbers: PAT‑1251‑CL‑001
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No