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Clinical Trials/NCT03627845
NCT03627845
Completed
Phase 1

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

pH Pharma1 site in 1 country49 target enrollmentAugust 2, 2018
InterventionsPHP-303Placebo
DrugsPHP-303

Overview

Phase
Phase 1
Intervention
PHP-303
Conditions
Healthy Volunteer
Sponsor
pH Pharma
Enrollment
49
Locations
1
Primary Endpoint
Plasma concentration of single oral dose of PHP-303 - t1/2
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2018
End Date
January 8, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
pH Pharma
Responsible Party
Sponsor

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.

Arms & Interventions

Experimental

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

Intervention: PHP-303

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Plasma concentration of single oral dose of PHP-303 - t1/2

Time Frame: Up to 9 weeks

Determination of half-life

Plasma concentration of single oral dose of PHP-303 - Cmax

Time Frame: Up to 9 weeks

Maximum observed concentration

Safety and tolerability of single oral dose of PHP-303 - Incidence of Adverse Events

Time Frame: Up to 9 weeks

Assess the number of patients with adverse events

Safety and tolerability of single oral dose of PHP-303 - blood pressure

Time Frame: Up to 9 weeks

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

Safety and tolerability of single oral dose of PHP-303 - number of patients with abnormal ECG

Time Frame: Up to 9 weeks

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

Safety and tolerability of single oral dose of PHP-303 - heart rate

Time Frame: Up to 9 weeks

Measured as number of heart beats per minute

Safety and tolerability of single oral dose of PHP-303 - respiratory rate

Time Frame: Up to 9 weeks

Measured by number of breaths per minute

Safety and tolerability of single oral dose of PHP-303 - body temperature

Time Frame: Up to 9 weeks

Measurement of oral body temperature

Plasma concentration of single oral dose of PHP-303 - AUC

Time Frame: Up to 9 weeks

Area under the curve

Study Sites (1)

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