Clinical trial NCT01727791: A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
Official title: A Multiple Dose Pharmacokinetic Open-label Study Of Pregabalin (Lyrica Registered) In Healthy Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Lactating Women
Keywords: pharmacokinetic
pregabalin
lactation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Post approval commitment for the FDA

Eligibility 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).

Primary outcomes:
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
measure: Plasma Half-Life (t1/2)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
measure: Average Plasma Concentration During the Dosing Interval (Cav)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
measure: Apparent Oral Clearance (CL/F)
timeFrame: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
measure: Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
measure: Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
measure: Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
measure: Average Breast Milk Concentration During the Dosing Interval (Cav)
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Breast Milk Clearance (CLbm)
timeFrame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Renal Clearance (CLr)
timeFrame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3
measure: Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)
timeFrame: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Milk to Plasma Ratio for AUCtau (MPAUCtau)
timeFrame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)
timeFrame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
measure: Body Weight Normalized Infant Dose (BWNID)
timeFrame: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
measure: Body Weight Normalized Maternal Dose (BWNMD)
timeFrame: Pre-dose to 24 hours post-dose on Day 3
measure: Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)
timeFrame: Pre-dose to 24 hours post-dose on Day 3
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose of study drug
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to 28 days after last dose of study drug
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline up to 28 days after last dose of study drug
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: