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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627845
• Other study ID #: PHP-303-N101
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2018
• Est. completion date: January 8, 2020

Study information

• Verified date: March 2019
• Source: pH Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: January 8, 2020
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• PHP-303
Investigational drug

Other:
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Vince & Associates Clinical Research, Inc.	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
pH Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Safety and tolerability of single oral dose of PHP-303 - heart rate	Measured as number of heart beats per minute	Up to 9 weeks
Primary	Safety and tolerability of single oral dose of PHP-303 - body temperature	Measurement of oral body temperature	Up to 9 weeks
Primary	Safety and tolerability of single oral dose of PHP-303 - respiratory rate	Measured by number of breaths per minute	Up to 9 weeks
Primary	Plasma concentration of single oral dose of PHP-303 - AUC	Area under the curve	Up to 9 weeks
Primary	Plasma concentration of single oral dose of PHP-303 - Cmax	Maximum observed concentration	Up to 9 weeks
Primary	Plasma concentration of single oral dose of PHP-303 - t1/2	Determination of half-life	Up to 9 weeks