A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
- Conditions
- Otherwise Healthy Overweight or Obese
- Interventions
- Other: Placebo
- Registration Number
- NCT03775278
- Lead Sponsor
- pH Pharma
- Brief Summary
This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Male or female subjects, ≥ 18 to ≤ 60 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, multiple oral dose, up to 5 ascending dose cohorts Experimental PHP-303 PHP-303, multiple oral dose, up to 5 ascending dose cohorts
- Primary Outcome Measures
Name Time Method Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events Up to 12 weeks Assess the number of patients with adverse events
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG Up to 12 weeks Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure Up to 12 weeks Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Safety and tolerability of multiple oral doses of PHP-303 - heart rate Up to 12 weeks Measured as number of heart beats per minute
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate Up to 12 weeks Measured by number of breaths per minute
Plasma concentration of multiple oral doses of PHP-303 - AUC Plasma Up to 12 weeks Area under the curve
Plasma concentration of multiple oral doses of PHP-303 - t1/2 Up to 12 weeks Determination of half-life
Safety and tolerability of multiple oral doses of PHP-303 - body temperature Up to 12 weeks Measurement of oral body temperature
Plasma concentration of multiple oral doses of PHP-303 - Cmax Up to 12 weeks Maximum observed concentration
Plasma concentration of multiple oral doses of PHP-303 - Tmax Up to 12 weeks Time to reach maximum measured plasma concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vince & Associates Clinical Research, Inc.
🇺🇸Overland Park, Kansas, United States