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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Other: Placebo; Drug: PHP-303

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince & Associates Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; PHP-303, single oral dose, up to 6 ascending dose cohorts	Drug: PHP-303; Investigational drug
PLACEBO_COMPARATOR: Placebo; Placebo, single oral dose, up to 6 ascending dose cohorts	Other: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of single oral dose of PHP-303 - Incidence of Adverse Events	Assess the number of patients with adverse events	Up to 9 weeks
Safety and tolerability of single oral dose of PHP-303 - number of patients with abnormal ECG	Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters	Up to 9 weeks
Safety and tolerability of single oral dose of PHP-303 - blood pressure	Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure	Up to 9 weeks
Safety and tolerability of single oral dose of PHP-303 - heart rate	Measured as number of heart beats per minute	Up to 9 weeks
Safety and tolerability of single oral dose of PHP-303 - body temperature	Measurement of oral body temperature	Up to 9 weeks
Safety and tolerability of single oral dose of PHP-303 - respiratory rate	Measured by number of breaths per minute	Up to 9 weeks
Plasma concentration of single oral dose of PHP-303 - AUC	Area under the curve	Up to 9 weeks
Plasma concentration of single oral dose of PHP-303 - Cmax	Maximum observed concentration	Up to 9 weeks
Plasma concentration of single oral dose of PHP-303 - t1/2	Determination of half-life	Up to 9 weeks

Collaborators and Investigators

• Sponsor: pH Pharma
• Investigators: Study Chair: Brian Roberts, MD, pH Pharma Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2018
• Primary Completion (ACTUAL): December 5, 2018
• Study Completion (ACTUAL): January 8, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (ACTUAL): August 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PHP-303-N101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No