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A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775278
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Otherwise Healthy Overweight or Obese Drug: PHP-303 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 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, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : July 24, 2019
Actual Study Completion Date : April 7, 2020

Arm Intervention/treatment
Experimental: Experimental
PHP-303, multiple oral dose, up to 5 ascending dose cohorts
Drug: PHP-303
Investigational drug

Placebo Comparator: Placebo
Placebo, multiple oral dose, up to 5 ascending dose cohorts
Other: Placebo
Matching placebo




Primary Outcome Measures :
  1. Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events [ Time Frame: Up to 12 weeks ]
    Assess the number of patients with adverse events

  2. Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG [ Time Frame: Up to 12 weeks ]
    Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters

  3. Safety and tolerability of multiple oral doses of PHP-303 - blood pressure [ Time Frame: Up to 12 weeks ]
    Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure

  4. Safety and tolerability of multiple oral doses of PHP-303 - heart rate [ Time Frame: Up to 12 weeks ]
    Measured as number of heart beats per minute

  5. Safety and tolerability of multiple oral doses of PHP-303 - body temperature [ Time Frame: Up to 12 weeks ]
    Measurement of oral body temperature

  6. Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate [ Time Frame: Up to 12 weeks ]
    Measured by number of breaths per minute

  7. Plasma concentration of multiple oral doses of PHP-303 - AUC [ Time Frame: Plasma Up to 12 weeks ]
    Area under the curve

  8. Plasma concentration of multiple oral doses of PHP-303 - Cmax [ Time Frame: Up to 12 weeks ]
    Maximum observed concentration

  9. Plasma concentration of multiple oral doses of PHP-303 - Tmax [ Time Frame: Up to 12 weeks ]
    Time to reach maximum measured plasma concentration

  10. Plasma concentration of multiple oral doses of PHP-303 - t1/2 [ Time Frame: Up to 12 weeks ]
    Determination of half-life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775278


Locations
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United States, Kansas
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
pH Pharma
Investigators
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Study Chair: Andrew Nicholls, MD, PhD pH Pharma Inc
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Responsible Party: pH Pharma
ClinicalTrials.gov Identifier: NCT03775278    
Other Study ID Numbers: PHP-303-N102
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight