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

NCT03627845 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PHP-303-N101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

PHP-303, single oral dose, up to 6 ascending dose cohorts

Drug: PHP-303

Placebo

PLACEBO COMPARATOR

Placebo, single oral dose, up to 6 ascending dose cohorts

Other: Placebo

Interventions

PHP-303 DRUG

Investigational drug

Experimental

Placebo OTHER

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• pH Pharma: lead

Study Sites (1)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

Study Officials

• Brian Roberts, MD

  pH Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 13, 2018
• Study Start: August 2, 2018
• Primary Completion: December 5, 2018
• Study Completion: January 8, 2020
• Last Updated: April 13, 2020

Record last verified: 2019-03

Locations

US (1)