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A Phase I Study in Healthy Volunteers

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: NCT03784300
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
PainT ( Pain Therapeutics )

Brief Summary:
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers

Condition or disease Intervention/treatment Phase
Pharmacokinetics and Safety in Healthy Volunteers Drug: 50 mg PTI-125 Drug: 100 mg PTI-125 Drug: 200 mg PTI-125 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, randomized, double-blind, placebo controlled, SAD study of three escalating doses of PTI-125. A total of 24 healthy subjects enrolled in one of three dose cohorts. Each cohort will contain 8 subjects; six receive PTI-125 and two receive placebo. Three SAD does of PTI-125 oral solution (50, 100 or 200 mg) or placebo solution will be administered.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers
Actual Study Start Date : August 18, 2017
Actual Primary Completion Date : October 9, 2017
Actual Study Completion Date : March 27, 2018

Arm Intervention/treatment
Active Comparator: 50 mg PTI-125
Six (6) subjects will receive a single orally administered dose of 50 mg PTI-125 in this cohort.
Drug: 50 mg PTI-125
PTI-125 50 mg Oral Solution

Placebo Comparator: 50 mg PTI-125 Placebo
Two (2) subjects will receive a single orally administered dose of 50 mg Placebo PTI-125 in this cohort.
Drug: 50 mg PTI-125
PTI-125 50 mg Oral Solution

Active Comparator: 100 mg PTI-125
Six (6) subjects will receive a single orally administered dose of 100 mg PTI-125 in this cohort.
Drug: 100 mg PTI-125
PTI-125 100 mg Oral Solution

Placebo Comparator: 100 mg PTI-125 Placebo
Two (2) subjects will receive a single orally administered dose of 100 mg Placebo PTI-125 in this cohort.
Drug: 100 mg PTI-125
PTI-125 100 mg Oral Solution

Active Comparator: 200 mg PTI-125
Six (6) subjects will receive a single orally administered dose of 200 mg PTI-125 in this cohort.
Drug: 200 mg PTI-125
PTI-125 200 mg Oral Solution

Placebo Comparator: 200 mg PTI-125 Placebo
Two (2) subjects will receive a single orally administered dose of 200 mg Placebo PTI-125 in this cohort.
Drug: 200 mg PTI-125
PTI-125 200 mg Oral Solution




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The peak drug concentration will be obtained directly from the data without interpolation.

  2. Time to Maximum Plasma Concentration (Tmax) (Tmax) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The time to peak drug concentration will be obtained directly from the data without interpolation

  3. Time to Last Quantifiable Plasma Concentration (Tlast) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The time to the last quantifiable drug concentration will be obtained directly from the data without interpolation.

  4. Last Quantifiable Plasma Concentration (Clast) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The concentration of the last quantifiable drug will be obtained directly from the data without interpolation concentration

  5. Elimination Rate Constant (λz) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The elimination rate constant (λz) will be calculated.

  6. Termination Elimination Half-Life (T1/2) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The terminal elimination half-life (T1/2) will be calculated.

  7. Area Under the Curve (AUC) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The AUC from time zero to the time of the last quantifiable concentration (AUClast) will be calculated.

  8. Area Under the Curve to Infinity (AUCinf) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The AUC from time zero extrapolated to infinity (AUCinf) will be calculate.

  9. The Percentage of Area Under the Curve to Infinity (AUCextrap(%). [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The percentage of AUCinf based on extrapolation (AUCextrap(%) will be calculated.

  10. Oral Clearance (Cl/F) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    The apparent oral clearance will be calculated.

  11. Volume of Distribution (Vz/F) [ Time Frame: Blood samples will be drawn on Day 1 after dosing at 20, 40, and 60 minutes and at 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours. ]
    Vz/F, apparent volume of distribution will be calculated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 and 45 years of age, inclusive.
  • The subject has a body mass index (BMI) within 18-30 kg/m2 (inclusive).
  • The subject is in good health as determined by medical history and physical examination and clinical laboratory parameters.
  • The subject is willing and able to speak, read, and understand English and provide written informed consent.
  • The subject is a non-smoker for at least 12 months. If a former smoker, the reason for stopping must be evaluated.
  • Females who are physically incapable of childbearing defined as postmenopausal, or surgically sterile (hysterectomy, bilateral tubal ligation, bilateral oophorectomy or an Essure procedure). Appropriate documentation (ex; medical record) of the surgical sterilization procedure to be obtained and held within the subject's study file.
  • The subject must agree to comply with the drawing of blood samples for the PK assessments.
  • The subject is willing and able to comply with all testing and requirements defined in the protocol.
  • The subject is willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit.

Exclusion Criteria:

  • The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.
  • The subject has had a clinically significant illness within 30 days of Check-in.
  • The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
  • The subject has used any prescription medication within 14 days of dosing or overthe- counter (OTC) medication within 48 h of dosing or intends to use any prescription medication or OTC medication during the study that may interfere with the evaluation of study medication.
  • The subject has used alcohol, caffeine or xanthine-containing products 48 h before dosing or intends to use any of these products during the study.
  • The subject has used grapefruit, grapefruit juice, or grapefruit-containing products days before dosing or intends to use any of these products during the study.
  • The subject has a history of substance abuse or a positive ethanol breath test, urine cotinine, or urine drug screen at screening or at check-in. The subject has a positive serum hepatitis B surface antigen or positive HCV antibody test at the Screening Visit.
  • The subject has a positive HIV test at the Screening Visit.
  • Female subject is pregnant or breastfeeding.
  • The subject has received an investigational drug within 30 days of Check-in.
  • The subject has donated or lost a significant volume of blood (>450 mL) within 4 weeks prior to the study.
  • The subject is unwilling to reside in the study unit for the duration of the study or to cooperate fully with the investigator or site personnel.
  • The subject has an AST/ALT or total bilirubin greater than the ULN. One repeat test will be allowed.

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): NCT03784300


Locations
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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Pain Therapeutics
National Institutes of Health (NIH)
Investigators
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Principal Investigator: George J Atiee, MD Worldwide Clinical Trials
  Study Documents (Full-Text)

Documents provided by PainT ( Pain Therapeutics ):
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Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT03784300    
Other Study ID Numbers: PTI-125-01
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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