NCT03183297

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001

A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Sen-Jam Pharmaceutical · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects.

Detailed description

This will be a double-blind, placebo-controlled study with a 4-way crossover design with subjects administered study drug (JMI-001), placebo, fexofenadine alone and naproxen alone on different study days, in conjunction with a quantity of alcohol estimated to be sufficient to produce a hangover the next day. The primary objective of the study is the evaluate the pharmacokinetics and pharmacodynamics of two different doses of JMI-001 administered in conjunction with alcohol to healthy adult subjects. The secondary objective of this study is to compare the PK characteristics of fexofenadine administered as JMI-001 with administration of fexofenadine alone, and the PK characteristics of naproxen administered as JMI-001 with administration of naproxen alone. To compare overall hangover severity after administering JMI-001 with overall hangover severity after administration of fexofenadine alone or naproxen alone. To analyze possible quantitative differences in symptom profiles by treatment.

Conditions

• Veisalgia

Interventions

Type	Name	Description
DRUG	JMI-001	JMI-001, a combination product of naproxen and fexofenadine
DRUG	Naproxen	Naproxen sodium 220mg
DRUG	Fexofenadine	Fexofenadine 60mg
DRUG	placebo	placebo comparator

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2017-06-12
• Last updated: 2017-06-12

Regulatory

• FDA-regulated drug study