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Completed

NCT Number: NCT03627845

A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PHP-303

Drug

Investigational drug

Placebo

Other

Matching placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

pH Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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