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

NCT ID: NCT03627845

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2020-01-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

PHP-303

Intervention Type: DRUG

Investigational drug

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo

Interventions

PHP-303

Investigational drug

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

pH Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Roberts, MD

Role: STUDY_CHAIR

pH Pharma Inc

Locations

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

PHP-303-N101

Identifier Type: -

Identifier Source: org_study_id