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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01727791
First received: November 12, 2012
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Healthy Lactating Women
Drug: pregabalin (Lyrica)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multiple Dose Pharmacokinetic Open Label Study Of Pregabalin (Lyrica) In Healthy Lactating Women

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Ae.tau.urine [Amount recovered in urine during the dosing interval, tau (12 hours)] [ Time Frame: over 12 hrs post Day 3 dose ] [ Designated as safety issue: No ]
  • "Area Under the Curve from Time Zero to end of dosing interval (AUCtau) (plasma and breast milk)" [ Time Frame: over 12 hrs post Day dose 3 ] [ Designated as safety issue: No ]
  • Clr [Renal clearance; Urine Ae(tau)/ Plasma AUC(tau)] [ Time Frame: over 12 hours post Day 3 dose ] [ Designated as safety issue: No ]
  • "Maximum Observed Plasma Concentration (Cmax) (plasma and breast milk)" [ Time Frame: over 48 hrs post Day 3 dose ] [ Designated as safety issue: No ]
  • "Time to Reach Maximum Observed Plasma Concentration (Tmax) (plasma and breast milk)" [ Time Frame: over 48 hrs post Day 3 dose ] [ Designated as safety issue: No ]
  • "Half-Life (t1/2) (plasma)" [ Time Frame: over 24 hrs post Day 3 dose ] [ Designated as safety issue: No ]
  • Caverage (plasma only) [ Time Frame: Over 12 hours post Day 3 dose ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) (plasma only) [ Time Frame: Pre Day 3 dose ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance (CL/F) (plasma only) [ Time Frame: over 12 hours post Day 3 dose ] [ Designated as safety issue: No ]
  • Ae.tau.bm [Amount excreted in breast milk over the dosing interval tau (12 hours)] [ Time Frame: over 12 hours post Day 3 dose ] [ Designated as safety issue: No ]
  • "CL.bm [Breast milk clearance Ae(tau)bm/plasma AUC(tau)]" [ Time Frame: over 12 hours post Day 3 dose ] [ Designated as safety issue: No ]
  • "Half-Life (t1/2) ( breast milk)" [ Time Frame: over 48 hours post Day 3 dose ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open label Drug: pregabalin (Lyrica)
Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.

Detailed Description:

Post approval commitment for the FDA

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727791

Locations
Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01727791     History of Changes
Other Study ID Numbers: A0081181
Study First Received: November 12, 2012
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pharmacokinetic
pregabalin
lactation

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014