Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date November 30, 2016
Study Start Date  ICMJE July 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: one to seven days ]
  • Area Under the Plasma Concentration Versus Time Curve (AUC) [ Time Frame: 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
  • Terminal elimination half-life (t½) [ Time Frame: one to seven days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PAT-1251
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: PAT-1251 Single Dose
    Oral solution of PAT-1251, 150 - 4000 mg administered once
    Intervention: Drug: PAT-1251
  • Placebo Comparator: Placebo Single Dose
    Matching placebo solution administered once
    Intervention: Drug: Placebo
  • Experimental: PAT-1251 Multiple Dose
    Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
    Intervention: Drug: PAT-1251
  • Experimental: Placebo Multiple Dose
    Matching placebo tablets administered daily for 7 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2016)
78
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852551
Other Study ID Numbers  ICMJE PAT-1251-CL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PharmAkea, Inc.
Study Sponsor  ICMJE PharmAkea, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kevin Holme, Ph.D. PharmAkea, Inc.
PRS Account PharmAkea, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP