A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women

Condition(s) targeted: Healthy Lactating Women

Intervention: pregabalin (Lyrica) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in healthy lactating women. The objectives are to determine whether pregabalin is secreted in breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other objectives are to estimate potential infant exposure to pregabalin if administered to lactating women and to characterize the safety and tolerability of pregabalin in lactating women.

Official title: A Multiple Dose Pharmacokinetic Open Label Study Of Pregabalin (Lyrica) In Healthy Lactating Women

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Area Under the Curve from Time Zero to end of dosing interval (AUCtau) (plasma and breast milk)

Maximum Observed Plasma Concentration (Cmax) (plasma and breast milk)

Time to Reach Maximum Observed Plasma Concentration (Tmax) (plasma and breast milk)

Plasma Decay Half-Life (t1/2) (plasma and breast milk)

Caverage (plasma only)

Minimum Observed Plasma Trough Concentration (Cmin) (plasma only)

Apparent Oral Clearance (CL/F) (plasma only)

Ae.tau.bm [Amount excreted in breast milk over the dosing interval tau (12 hours)]

CL.bm [Breast milk clearance Ae(tau)bm/plasma AUC(tau)]

Ae.tau.urine [Amount recovered in urine during the dosing interval, tau (12 hours)]

Clr [Renal clearance; Urine Ae(tau)/ Plasma AUC(tau)]

Detailed description: Post approval commitment for the FDA

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy lactating females between the ages of 18 and 45 years (inclusive) who are

actively breast-feeding or expressing breast milk and are at least 12 weeks post partum.

- Subjects must be willing to temporarily discontinue breast feeding their infants

before the Day 1 evening dose through to 42 hours after the last dose

Exclusion Criteria:

- History of significant adverse reaction to pregabalin or gabapentin.

- Subjects pregnant or unwilling or unable to comply with the Lifestyle guidelines

presented in the protocol during the study period and through the follow-up visit.

- Subjects with evidence or history of clinically significant hematological, renal,

endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including post natal depression), neurologic or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing).

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Clinical Research Unit, Bruxelles B-1070, Belgium; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: December 2012
Last updated: January 29, 2013