NCT02960568

Genetic Variability in CYP2D6 in U.S Active Duty Population

Genetic Variability in the Cytochrome P-450 Isoenzyme 2D6 (CYP2D6) in an Active Duty U.S. Military Population and the Impact of CYP2D6 Phenotype on Primaquine Metabolism.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Walter Reed Army Institute of Research (WRAIR) · Federal
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The investigator proposes to 2D6 (Cytochrome P-450 Isoenzyme 2D6) genotype and phenotype a group of active duty service members and assess the effects on primaquine metabolism.

Detailed description

The investigator propose to enroll a group of active duty service members in order to determine individuals' 2D6 isoenzyme genotype, an enzyme belonging to the hepatic cytochrome P450 oxidase system. The 2D6 isoenzyme is a key enzyme involved in the metabolism of many drugs including the anti-malarial drug primaquine (PQ). By knowing the genotype, the investigator can then categorize each volunteer by CYP2D6 phenotype i.e., expected impact on drug metabolism. In order to further substantiate the relationship between CYP2D6 activity, inadequate metabolism and subsequent primaquine failure, the investigator proposes to assess the effect of 2D6 genetic polymorphisms on PQ metabolism by measuring the PQ pharmacokinetics (PK) over 24 hours following a single 30 mg oral dose in a subset of these Active Duty subjects.

Conditions

• Pharmacologic Action

Interventions

Type	Name	Description
DRUG	Primaquine	30 mg oral primaquine one time

Timeline

• Start date: 2016-01-08
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2016-11-09
• Last updated: 2021-10-20

Locations

1 site across 1 country: United States