Renal Impairment
Conditions
Keywords
Gabapentin Pharmacokinetics
Brief summary
The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was used for the evidence of the dose adjustment for the patients with renal impairment, and observed plasma gabapentin concentration.
Detailed description
Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.
Interventions
DRUGGabapentin
100-200mg once a day
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Japanese epilepsy patients with renal impairment
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observed Plasma Gabapentin Concentration | Days 8 and 15 | Plasma gabapentin concentrations were measured on Day 8 and Day 15 |
| Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | Days 8 and 15 | Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively. |
| Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Days 8 and 15 | Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively. |
Countries
Japan
Participant flow
Recruitment details
Study Initiation Date and Completion Dates: 16 March 2010 to 1 April 2010 Study Center: 1 center in Japan
Pre-assignment details
A subject who had already been taking gabapentin was enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin The dosage regimens were adjusted depending on the creatinine clearance. Duration of observation was 15 days from screening if the subject had already been treated with gabapentin and 28 days from screening if the subject was treated with gabapentin for the first time.
The subject enrolled was on hemodialysis, receiving a maintenance dose of 300 mg twice daily for 15 days. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Gabapentin |
|---|---|
| Age, Customized <=19 years | 0 Participant |
| Age, Customized 20-64 years | 1 Participant |
| Age, Customized >=65 years | 0 Participant |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Observed Plasma Gabapentin Concentration
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Time frame: Days 8 and 15
Population: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gabapentin | Observed Plasma Gabapentin Concentration | Day 8 | 38.40 µg/mL |
| Gabapentin | Observed Plasma Gabapentin Concentration | Day 15 | 44.64 µg/mL |
Primary
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Time frame: Days 8 and 15
Population: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gabapentin | Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Day 8 | 1.15 Ratio |
| Gabapentin | Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration | Day 15 | 1.37 Ratio |
Primary
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
Time frame: Days 8 and 15
Population: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gabapentin | Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | Day 8 | 2.16 Ratio |
| Gabapentin | Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model | Day 15 | 2.59 Ratio |