A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01727791
First received: November 12, 2012
Last updated: April 29, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Urine and Urination
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Area Under the Curve from Time Zero to end of dosing interval (AUCtau) (plasma and breast milk) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ] [ Designated as safety issue: No ]
- Maximum Observed Plasma Concentration (Cmax) (plasma and breast milk) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ] [ Designated as safety issue: No ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) (plasma and breast milk) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ]
- Plasma Decay Half-Life (t1/2) (plasma and breast milk) [ Time Frame: 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ] [ Designated as safety issue: No ]
- Caverage (plasma only) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ] [ Designated as safety issue: No ]
- Minimum Observed Plasma Trough Concentration (Cmin) (plasma only) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ] [ Designated as safety issue: No ]
- Apparent Oral Clearance (CL/F) (plasma only) [ Time Frame: 0.5, 1, 2, 3, 4, 6, 10, and 12 hours post dose on Day 3 ] [ Designated as safety issue: No ]
- Ae.tau.bm [Amount excreted in breast milk over the dosing interval tau (12 hours)] [ Time Frame: 0 to 2 hours, 2 to 4 hours, 4 to 8 hours, 8 to 12 and 12 to 24 hrs post Day 3 dose ] [ Designated as safety issue: No ]
- CL.bm [Breast milk clearance Ae(tau)bm/plasma AUC(tau)] [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
- Ae.tau.urine [Amount recovered in urine during the dosing interval, tau (12 hours)] [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
- Clr [Renal clearance; Urine Ae(tau)/ Plasma AUC(tau)] [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 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 committment 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727791
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Belgium | |
| Pfizer Clinical Research Unit | Recruiting |
| Bruxelles, 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: | April 29, 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 |
ClinicalTrials.gov processed this record on May 19, 2013