Back to resultsA Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
Primary Purpose
Otherwise Healthy Overweight or Obese
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PHP-303
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Otherwise Healthy Overweight or Obese
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.
Sites / Locations
- Vince & Associates Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo
Arm Description
PHP-303, multiple oral dose, up to 5 ascending dose cohorts
Placebo, multiple oral dose, up to 5 ascending dose cohorts
Outcomes
Primary Outcome Measures
Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
Assess the number of patients with adverse events
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
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
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
Measured as number of heart beats per minute
Safety and tolerability of multiple oral doses of PHP-303 - body temperature
Measurement of oral body temperature
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
Measured by number of breaths per minute
Plasma concentration of multiple oral doses of PHP-303 - AUC
Area under the curve
Plasma concentration of multiple oral doses of PHP-303 - Cmax
Maximum observed concentration
Plasma concentration of multiple oral doses of PHP-303 - Tmax
Time to reach maximum measured plasma concentration
Plasma concentration of multiple oral doses of PHP-303 - t1/2
Determination of half-life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03775278
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
April 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pH Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otherwise Healthy Overweight or Obese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
PHP-303, multiple oral dose, up to 5 ascending dose cohorts
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, multiple oral dose, up to 5 ascending dose cohorts
Intervention Type
Drug
Intervention Name(s)
PHP-303
Intervention Description
Investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
Description
Assess the number of patients with adverse events
Time Frame
Up to 12 weeks
Title
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
Description
Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Time Frame
Up to 12 weeks
Title
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
Description
Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Time Frame
Up to 12 weeks
Title
Safety and tolerability of multiple oral doses of PHP-303 - heart rate
Description
Measured as number of heart beats per minute
Time Frame
Up to 12 weeks
Title
Safety and tolerability of multiple oral doses of PHP-303 - body temperature
Description
Measurement of oral body temperature
Time Frame
Up to 12 weeks
Title
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
Description
Measured by number of breaths per minute
Time Frame
Up to 12 weeks
Title
Plasma concentration of multiple oral doses of PHP-303 - AUC
Description
Area under the curve
Time Frame
Plasma Up to 12 weeks
Title
Plasma concentration of multiple oral doses of PHP-303 - Cmax
Description
Maximum observed concentration
Time Frame
Up to 12 weeks
Title
Plasma concentration of multiple oral doses of PHP-303 - Tmax
Description
Time to reach maximum measured plasma concentration
Time Frame
Up to 12 weeks
Title
Plasma concentration of multiple oral doses of PHP-303 - t1/2
Description
Determination of half-life
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Nicholls, MD, PhD
Organizational Affiliation
pH Pharma Inc
Official's Role
Study Chair
Facility Information:
Facility Name
Vince & Associates Clinical Research, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
We'll reach out to this number within 24 hrs