Phase 4
Completed N=10
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
Healthy Lactating Women
Source: ClinicalTrials.gov NCT01727791 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) — 32.50 microgram*hour/milliliter (mcg*hr/mL)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
32.50 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
4.67 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
2.01 | — |
| PRIMARY Plasma Half-Life (t1/2) |
5.624 | — |
| PRIMARY Average Plasma Concentration During the Dosing Interval (Cav) |
2.709 | — |
| PRIMARY Minimum Observed Plasma Trough Concentration (Cmin) |
1.246 | — |
| PRIMARY Apparent Oral Clearance (CL/F) |
76.90 | — |
| PRIMARY Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk]) |
24.64 | — |
| PRIMARY Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk]) |
2.474 | — |
| PRIMARY Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk]) |
4.63 | — |
| PRIMARY Terminal Half-Life for Breast Milk (t1/2 [Breast Milk]) |
8.117 | — |
| PRIMARY Average Breast Milk Concentration During the Dosing Interval (Cav) |
2.116 | — |
| PRIMARY Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm) |
286.9 | — |
| PRIMARY Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent) |
0.1913 | — |
| PRIMARY Breast Milk Clearance (CLbm) |
0.1473 | — |
| PRIMARY Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine) |
133.1 | — |
| PRIMARY Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent) |
88.6 | — |
| PRIMARY Renal Clearance (CLr) |
68.16 | — |
| PRIMARY Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm) |
664.6 | — |
| PRIMARY Milk to Plasma Ratio for AUCtau (MPAUCtau) |
0.769 | — |
| PRIMARY Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax) |
0.5413 | — |
| PRIMARY Body Weight Normalized Infant Dose (BWNID) |
317.3 | — |
| PRIMARY Body Weight Normalized Maternal Dose (BWNMD) |
4343.6 | — |
| PRIMARY Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM) |
7.341 | — |
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).
Data sourced from ClinicalTrials.gov (NCT01727791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.