A Safety Study of PTI-125 in Healthy Volunteers

• Status: Completed
• Trial end date: 2018-03-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pain Therapeutics
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)

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.