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A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy 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: NCT03627845
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
pH Pharma

Tracking Information
First Submitted Date  ICMJE July 31, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date April 13, 2020
Actual Study Start Date  ICMJE August 2, 2018
Actual Primary Completion Date December 5, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Safety and tolerability of single oral dose of PHP-303 - Incidence of Adverse Events [ Time Frame: Up to 9 weeks ]
    Assess the number of patients with adverse events
  • Safety and tolerability of single oral dose of PHP-303 - number of patients with abnormal ECG [ Time Frame: Up to 9 weeks ]
    Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
  • Safety and tolerability of single oral dose of PHP-303 - blood pressure [ Time Frame: Up to 9 weeks ]
    Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
  • Safety and tolerability of single oral dose of PHP-303 - heart rate [ Time Frame: Up to 9 weeks ]
    Measured as number of heart beats per minute
  • Safety and tolerability of single oral dose of PHP-303 - body temperature [ Time Frame: Up to 9 weeks ]
    Measurement of oral body temperature
  • Safety and tolerability of single oral dose of PHP-303 - respiratory rate [ Time Frame: Up to 9 weeks ]
    Measured by number of breaths per minute
  • Plasma concentration of single oral dose of PHP-303 - AUC [ Time Frame: Up to 9 weeks ]
    Area under the curve
  • Plasma concentration of single oral dose of PHP-303 - Cmax [ Time Frame: Up to 9 weeks ]
    Maximum observed concentration
  • Plasma concentration of single oral dose of PHP-303 - t1/2 [ Time Frame: Up to 9 weeks ]
    Determination of half-life
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects
Official Title  ICMJE A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Healthy Subjects
Brief Summary This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in healthy volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 3:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability of orally-administered PHP-303.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: PHP-303
    Investigational drug
  • Other: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: Experimental
    PHP-303, single oral dose, up to 6 ascending dose cohorts
    Intervention: Drug: PHP-303
  • Placebo Comparator: Placebo
    Placebo, single oral dose, up to 6 ascending dose cohorts
    Intervention: Other: 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: December 12, 2018)
49
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
48
Actual Study Completion Date  ICMJE January 8, 2020
Actual Primary Completion Date December 5, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, ≥ 18 to ≤ 55 years of age.
  • In good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ECG at Screening, in the opinion of an Investigator.
  • Willing to forego other forms of experimental treatment during the study.

Exclusion Criteria:

  • Any clinically significant condition that, in the opinion of an Investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements.
  • Major surgery in the 6 months preceding Screening.
  • Clinically-significant abnormal laboratory parameters.
  • Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening or on admission to the study site.
  • Electrocardiographic Fridericia's corrected QT interval (QTcF) interval > 450 msec for males and > 470 msec for females, or any other clinically significant electrocardiographic abnormality.
  • Blood pressure results > 150 mmHg systolic or > 95 mmHg diastolic
  • Female subject who is pregnant (positive pregnancy test at the Screening Visit or on admission to the study site), lactating, or planning to become pregnant during the study period or within 3 months after the final dose of study medication.
  • History of drug or alcohol abuse or dependence within 1 year prior to Screening.
  • History of cigarette smoking within 3 months of Screening.
  • Known intolerance to lactose.
  • Regular use of prescription drugs within 14 days of the first administration of study drug or non-prescription (over-the-counter) drugs within 7 days of the first administration of study drug or unwilling to abstain from prohibited medications through the end of study.
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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03627845
Other Study ID Numbers  ICMJE PHP-303-N101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party pH Pharma
Study Sponsor  ICMJE pH Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Brian Roberts, MD pH Pharma Inc
PRS Account pH Pharma
Verification Date March 2019

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