A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects

This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.

Study Overview

• Status: Completed
• Conditions: Otherwise Healthy Overweight or Obese
• Intervention / Treatment: Other: Placebo; Drug: PHP-303

• Study Type: Interventional
• Enrollment (Actual): 50
• 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 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects, ≥ 18 to ≤ 60 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, multiple oral dose, up to 5 ascending dose cohorts	Drug: PHP-303; Investigational drug
PLACEBO_COMPARATOR: Placebo; Placebo, multiple oral dose, up to 5 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 multiple oral doses of PHP-303 - Incidence of Adverse Events	Assess the number of patients with adverse events	Up to 12 weeks
Safety and tolerability of multiple oral doses 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 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure	Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure	Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - heart rate	Measured as number of heart beats per minute	Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - body temperature	Measurement of oral body temperature	Up to 12 weeks
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate	Measured by number of breaths per minute	Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - AUC	Area under the curve	Plasma Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - Cmax	Maximum observed concentration	Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - Tmax	Time to reach maximum measured plasma concentration	Up to 12 weeks
Plasma concentration of multiple oral doses of PHP-303 - t1/2	Determination of half-life	Up to 12 weeks

Collaborators and Investigators

• Sponsor: pH Pharma
• Investigators: Study Chair: Andrew Nicholls, MD, PhD, pH Pharma Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2018
• Primary Completion (ACTUAL): July 24, 2019
• Study Completion (ACTUAL): April 7, 2020

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (ACTUAL): December 13, 2018

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: PHP-303-N102

Drug and device information, study documents

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