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

• Sponsor: pH Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03627845
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: PHP-303; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 2, 2018
• Actual Primary Completion Date: Dec 5, 2018
• Actual Study Completion Date: Jan 8, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of single oral dose of PHP-303 - Incidence of Adverse Events [Up to 9 weeks]

   Assess the number of patients with adverse events

2. Safety and tolerability of single oral dose of PHP-303 - number of patients with abnormal ECG [Up to 9 weeks]

   Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters

3. Safety and tolerability of single oral dose of PHP-303 - blood pressure [Up to 9 weeks]

   Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure

4. Safety and tolerability of single oral dose of PHP-303 - heart rate [Up to 9 weeks]

   Measured as number of heart beats per minute

5. Safety and tolerability of single oral dose of PHP-303 - body temperature [Up to 9 weeks]

   Measurement of oral body temperature

6. Safety and tolerability of single oral dose of PHP-303 - respiratory rate [Up to 9 weeks]

   Measured by number of breaths per minute

7. Plasma concentration of single oral dose of PHP-303 - AUC [Up to 9 weeks]

   Area under the curve

8. Plasma concentration of single oral dose of PHP-303 - Cmax [Up to 9 weeks]

   Maximum observed concentration

9. Plasma concentration of single oral dose of PHP-303 - t1/2 [Up to 9 weeks]

   Determination of half-life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vince & Associates Clinical Research, Inc.	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

• pH Pharma

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: pH Pharma
• ClinicalTrials.gov Identifier: NCT03627845
• Other Study ID Numbers: PHP-303-N101
• First Posted: Aug 13, 2018
• Last Update Posted: Apr 13, 2020
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 13, 2020