NCT04265456

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (Ofirmev®) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Nevakar, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose (MTD) 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. Up to 60 subjects will be enrolled into one (1) of six (6) sequential cohorts (n=10 per cohort \[8 APAP + PGB and 2 placebo\]). The dose for the first cohort will be 1300 mg APAP and 100 mg PGB. For subsequent cohorts, the dose of APAP will remain constant at 1300 mg while the dose of PGB will be varied (will start with 100 mg TID and then based on tolerability will be either increased or decreased by 25 mg) based on Safety Monitoring Committee decision. The placebo will be the saline solution.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Pregabalin 100mg	Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.
DRUG	Acetaminophen 1300mg	Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.

Timeline

• Start date: 2020-01-14
• Primary completion: 2020-06-15
• Completion: 2020-07-22
• First posted: 2020-02-11
• Last updated: 2020-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study