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Status:

COMPLETED

A Safety Study of PTI-125 in Healthy Volunteers

Lead Sponsor:

Pain Therapeutics

Collaborating Sponsors:

National Institute on Aging (NIA)

Conditions:

Alzheimer Disease, Early Onset

Alzheimer Disease

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

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

Detailed Description

This was a Phase I, single center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy volunteers, 18 to 45 years of age. A total of twenty-four (24) subjects we...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 18 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 27 2018

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT03784300

Start Date

August 18 2017

End Date

March 27 2018

Last Update

May 10 2021

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San Antonio, Texas, United States, 78217