A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03627845
• Recruitment Status: Completed
• First Posted: August 13, 2018
• Last Update Posted: April 13, 2020
• Sponsor: pH Pharma
• Information provided by (Responsible Party): pH Pharma

Tracking Information

• First Submitted Date: July 31, 2018
• First Posted Date: August 13, 2018
• Last Update Posted Date: April 13, 2020
• Actual Study Start Date: August 2, 2018
• Actual Primary Completion Date: December 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Healthy Volunteer

Intervention

• Drug: PHP-303
  Investigational drug
• Other: Placebo
  Matching placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 12, 2018): 49
• Original Estimated Enrollment (submitted: August 8, 2018): 48
• Actual Study Completion Date: January 8, 2020
• Actual Primary Completion Date: December 5, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03627845
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: pH Pharma
• Original Responsible Party: Same as current
• Current Study Sponsor: pH Pharma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Brian Roberts, MD; pH Pharma Inc

• PRS Account: pH Pharma
• Verification Date: March 2019