A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy

• Status: Withdrawn
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary research question of this study is: Does the pharmacokinetics of oseltamivir after a single oral dose differ between the pregnant and non-pregnant women?

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• For Oseltamivir (Tamiflu) arm:

• Singleton gestation prior to 24 0/7 weeks gestation

• Planning to undergo a termination procedure for the incident pregnancy

• Willingness to take the single-dose medication and to follow study procedures

• Able to undergo informed consent.

• For Esterase arm:

• Singleton gestation greater than 32 completed weeks and less than 40 completed weeks of gestation

• Absence of severe pregnancy complication that could affect body volume and or metabolism (i.e., preeclampsia, renal dysfunction, hepatic dysfunction [defined as serum creatinine clearance of < 30 ml/min or a known ALT/AST> 2x facility normal value], etc.)

• Willingness to follow study procedures

• Able to undergo informed consent

• The use of medications that may affect renal metabolism is not a contraindication to participation since these subjects are only undergoing PK sampling.

Exclusion Criteria:

• For Oseltamivir (Tamiflu) arm:

• Known current in utero fetal death

• Significant medical history and/or medication use as determined by the investigator that has the potential to affect results of the study or put the patient at risk from the single-dosing

• Known hypersensitivity to the components of the study drug

• Known hepatic or renal dysfunction (defined as serum creatinine clearance of < 30 ml/min or a known ALT/AST> 2x facility normal value)

• Chronic use of street drugs (obtained via subject interview and/or medical history)

• Participation in any other concurrent interventional study.

• We will ask if they have a history of depression in the past requiring treatment or if they are currently actively depressed. If either of these questions yields a positive response, we will not consider the patient eligible and will not enroll the subject.

• For Esterase arm:

• Known current in utero fetal death

• Significant medical history as determined by the investigator to potentially affect results of the study

• Chronic use of street drugs (obtained via subject interview and/or medical history

• Participation in any other concurrent interventional study.