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

Completed · Phase 1 · Has a placebo group

Conditions studied: Postoperative Pain

In brief

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.

Key facts

Study ID: NCT04265456
Run by: Nevakar, Inc.
People needed: 63
Starts: 2020-01-14
Expected to finish: 2020-07-22
Last updated by the study team: 2020-08-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Lotus Clinical Resarch,LLC — Pasadena, California, United States

Full record on ClinicalTrials.gov

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