Trial Outcomes & Findings for A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women (NCT NCT01727791)

NCT ID: NCT01727791

Last Updated: 2021-01-28

Results Overview

Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3

Results posted on

2021-01-28

Participant Flow

Eligible participants were healthy, lactating females between the ages of 18 and 45 years (inclusive) who were actively breastfeeding or expressing breast milk, who were at least 12 weeks post-partum and not currently pregnant.

Participant milestones

Participant milestones
Measure	Pregabalin Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Age, Continuous	31.7 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3

Population: The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	32.50 microgramhour/milliliter (mcghr/mL) Geometric Coefficient of Variation 24

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Cmax was the peak concentration in plasma post Day 3 dose.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Maximum Observed Plasma Concentration (Cmax)	4.67 mcg/mL Geometric Coefficient of Variation 18

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Tmax was the time to peak concentration in plasma post Day 3 dose.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	2.01 hr Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Plasma Half-Life (t1/2)	5.624 hr Standard Deviation 0.65656

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Average Plasma Concentration During the Dosing Interval (Cav)	2.709 mcg/mL Geometric Coefficient of Variation 24

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Minimum Observed Plasma Trough Concentration (Cmin)	1.246 mcg/mL Geometric Coefficient of Variation 36

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Apparent Oral Clearance (CL/F)	76.90 mL/minute Geometric Coefficient of Variation 24

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])	24.64 mcg*hr/mL Geometric Coefficient of Variation 27

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])	2.474 mcg/mL Geometric Coefficient of Variation 30

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])	4.63 hr Interval 3.08 to 6.16

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

The terminal half-life for breast milk (t1/2 \[breast milk\]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])	8.117 hr Standard Deviation 3.0871

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Average Breast Milk Concentration During the Dosing Interval (Cav)	2.116 mcg/mL Full Range 27 • Interval 1.34 to 3.06

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration \* sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)	286.9 mcg Geometric Coefficient of Variation 60

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100\*(Aetaubm \[sum of {breast milk concentration \* sample volume} for each collection interval from 0 to 12 hours post-dose\] divided by dose), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)	0.1913 percentage of dose Geometric Coefficient of Variation 60

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of \[breast milk concentration \* sample volume\] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Breast Milk Clearance (CLbm)	0.1473 mL/min Geometric Coefficient of Variation 60

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration \* sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)	133.1 mg Geometric Coefficient of Variation 12

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100\* (Aetau \[sum of {urine concentration \* sample volume} for each collection interval from 0 to 12 hours post-dose\] divided by the dose), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)	88.6 percentage of dose Geometric Coefficient of Variation 12

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of \[urine concentration \* sample volume\] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Renal Clearance (CLr)	68.16 mL/min Geometric Coefficient of Variation 24

PRIMARY outcome

Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 \* Aetaubm (sum of \[breast milk concentration \* sample volume\] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)	664.6 mcg Full Range 60 • Interval 270.0 to 1720.0

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Milk to Plasma Ratio for AUCtau (MPAUCtau)	0.769 ratio Interval 0.493 to 0.956

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)	0.5413 ratio Interval 0.335 to 0.755

PRIMARY outcome

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

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day \[mL/kg/day\]), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Body Weight Normalized Infant Dose (BWNID)	317.3 mcg/kg/day Full Range 27 • Interval 202.0 to 458.0

PRIMARY outcome

Timeframe: Pre-dose to 24 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Body Weight Normalized Maternal Dose (BWNMD)	4343.6 mcg/kg/day Full Range 27 • Interval 3444.0 to 5676.0

PRIMARY outcome

Timeframe: Pre-dose to 24 hours post-dose on Day 3

Population: The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.

Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 \* BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)	7.341 percentage of dose Full Range 27 • Interval 4.43 to 9.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last dose of study drug

Population: The safety analysis population included participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Number of Participants with AEs	8 participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Number of Participants with SAEs	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last dose of study drug

Population: The safety analysis population included participants who received at least 1 dose of study medication.

The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume \[MCV\], mean corpuscular hemoglobin \[MCH\], mean corpuscular hemoglobin concentration \[MCHC\], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Number of Participants With Laboratory Abnormalities	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 28 days after last dose of study drug

Population: The safety analysis population included participants who received at least 1 dose of study medication.

The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.

Outcome measures

Outcome measures
Measure	Pregabalin n=10 Participants Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	0 participants

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pregabalin n=10 participants at risk Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Gastrointestinal disorders Dry mouth	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
General disorders Fatigue	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Musculoskeletal and connective tissue disorders Muscular weakness	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Nervous system disorders Dizziness	60.0% 6/10 • Number of events 9 • Baseline up to 28 days after last dose of study drug
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • Baseline up to 28 days after last dose of study drug
Nervous system disorders Restless legs syndrome	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug
Nervous system disorders Somnolence	10.0% 1/10 • Number of events 1 • Baseline up to 28 days after last dose of study drug

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER