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A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy 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: NCT03627845
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
pH Pharma

Study Description
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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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 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 Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Healthy Subjects
Actual Study Start Date : August 2, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : January 8, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
PHP-303, single oral dose, up to 6 ascending dose cohorts
 Drug: PHP-303
Investigational drug
Placebo Comparator: Placebo
Placebo, single oral dose, up to 6 ascending dose cohorts
 Other: Placebo
Matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Safety and tolerability of single oral dose of PHP-303 - body temperature [ Time Frame: Up to 9 weeks ]
    Measurement of oral body temperature

  6. 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

  7. Plasma concentration of single oral dose of PHP-303 - AUC [ Time Frame: Up to 9 weeks ]
    Area under the curve

  8. Plasma concentration of single oral dose of PHP-303 - Cmax [ Time Frame: Up to 9 weeks ]
    Maximum observed concentration

  9. Plasma concentration of single oral dose of PHP-303 - t1/2 [ Time Frame: Up to 9 weeks ]
    Determination of half-life


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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.
Contacts and Locations
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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): NCT03627845


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: Brian Roberts, MD pH Pharma Inc
More Information
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Responsible Party: pH Pharma
ClinicalTrials.gov Identifier: NCT03627845    
Other Study ID Numbers: PHP-303-N101
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No