A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers

• Status: Completed
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.

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

Details

• Lead Sponsor: Lotus Clinical Research, LLC; Nevakar, Inc.
• Collaborator: Nevakar, Inc
• Treatments: Acetaminophen; Pregabalin

Criteria

Inclusion Criteria:

• Male or female aged 18 to 55 years, inclusive at time of Screening

• Body mass index (BMI) between 18.5 and 28.0 kg/m2 inclusive, with a minimum weight of 50 kg and a maximum of 100 kg

• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination, and 12-lead ECG confirming normal sinus rhythm

• Negative tests for Hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus (HIV)-1 and HIV-2 antibody at Screening

• Routine clinical laboratory tests should be within normal limits at Screening and Admission (Day -1) or abnormalities deemed not clinically significant by the Investigator; for liver function tests, AST and ALT values should not be greater than 1.5 times the upper limit of normal range

• Negative screen for drugs of abuse or exhibit detectable alcohol levels by breathalyzer at the time of Screening or Admission

• Non-smokers or ex-smokers (must have ceased smoking ≥3 months prior Screening visit)

Female subjects:

• Must be of non-childbearing potential by surgical sterilization or postmenopausal OR Must not be pregnant, breast feeding, or planning to become pregnant AND must be practicing both a highly effective method of birth control from Screening until at least 90 days after the last dose of study drug.

• Women of childbearing potential must have a negative pregnancy test result at Screening and upon admission to the Clinical Trial Unit.

Exclusion Criteria:

• Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders

• Has a history of severe drug allergy, or severe hypersensitivity or severe food allergy, including anaphylaxis or known allergy or sensitivity to any component of PGB or APAP

• Has a history of alcoholism or drug abuse

• Has acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) at the time of Screening or Admission

• Consumption of drugs with enzyme-inducing properties, within 3 weeks prior to the initial dose of study drug and throughout the treatment phase

• Has used any prescription medicines, over the counter medicines, or herbal supplements, within 7 days of dosing

• Has used any investigational product or participated in any clinical trial within 30 days prior to Screening

• Has donated or received any blood or blood products within the 3 months prior to Screening;

• Not able to comply with the requirements of this study, including assessments, duration of admission of the study and expected follow up visits

• Is unwilling or unable to give written informed consent