NCT04285684

The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women

The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women: Quantification of Ketamine and Metabolites

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The Ketamine Research Foundation · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least 5 days apart.

Detailed description

Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least 5 days apart: 0.5mg/kg and 1.0mg kg. Women are required to have been breast feeding for at least 3 months and be healthy and on no medications. Support is provided for the entire time at the site and for any at home pumping. During the period of ketamine's influence, subjects are reclining and with 2 Investigators. The initial subject's data will determine the length of time for pumping--most likely 12 hours as ketamine and the active principle metabolite have half-lives of less than 3 hours. Determination of concentration of ketamine in breast milk is being done at the UCSF Clinical lab with quantification of metabolites that are inactive as well. This research is of benefit by providing lactating women information on potential exposure of infants/children to ketamine. It will serve as a guide as KRF conducts research on postpartum depression and for women at large using ketamine for psychiatric indications.

Conditions

• Ketamine
• Lactation

Interventions

Type	Name	Description
DRUG	ketamine in lactation	2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals

Timeline

• Start date: 2019-12-20
• Primary completion: 2021-01-05
• Completion: 2021-01-05
• First posted: 2020-02-26
• Last updated: 2021-12-13
• Results posted: 2021-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study