Clinical trial NCT03775278: A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Otherwise Healthy Overweight or Obese
Lead sponsor: pH Pharma
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
timeFrame: Up to 12 weeks
measure: Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
timeFrame: Up to 12 weeks
measure: Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
timeFrame: Up to 12 weeks
measure: Safety and tolerability of multiple oral doses of PHP-303 - heart rate
timeFrame: Up to 12 weeks
measure: Safety and tolerability of multiple oral doses of PHP-303 - body temperature
timeFrame: Up to 12 weeks
measure: Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
timeFrame: Up to 12 weeks
measure: Plasma concentration of multiple oral doses of PHP-303 - AUC
timeFrame: Plasma Up to 12 weeks
measure: Plasma concentration of multiple oral doses of PHP-303 - Cmax
timeFrame: Up to 12 weeks
measure: Plasma concentration of multiple oral doses of PHP-303 - Tmax
timeFrame: Up to 12 weeks
measure: Plasma concentration of multiple oral doses of PHP-303 - t1/2
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
Study officials:
affiliation: pH Pharma Inc
name: Andrew Nicholls, MD, PhD
role: STUDY_CHAIR
References: