Patients With Impaired Renal Function and HaemodialysisPhase 1NCT02629224
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis
A Phase 1 study testing ASP8825 in people with Patients With Impaired Renal Function and Haemodialysis, run by Astellas Pharma Inc at 2 sites in Japan.
Trial summary
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Patients With Impaired Renal Function and Haemodialysis
- What is being tested?
- ASP8825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight: ≥40.0 kg and <80.0 kg
- Body mass index BMI: ≥16.0 and <30.0 [BMI= Body weight (kg)/(Height (m))2]
- For Renal impairment patients: Patients with eGFR by GFR predictive equation for Japanese within < 50 mL.min/1.73m2 at screening and who is not undergoing dialysis
- For Haemodialysis patients: Patients who receive dialysis at screening
- Patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to dosing, or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before dosing to follow-up examination in the opinion of the investigator or sub-investigator.
- Female subjects who agree use effective contraception starting at informed consent and throughout the study period
Who cannot join
- Patients with a complication or history of the inappropriate for this study (except for a complication of primary disease for renal dysfunction, like diabetes etc., or complication of hypertension or anemia etc.)
- Patients with a complication or history of recurring alimentary disease
- Patients with a history of gastrointestinal surgical operation
- Patients with a complication of severe heart disease
- Patients with a complication or history of malignant tumor (However, a patient without recurrence of the malignant tumor for more than 5 years after the treatment may be eligible for the study.)
- Patients judged ineligible by the investigator or sub-investigator based on the results of medical examination, vital sign, 12-ECG and laboratory test
Show all 10Show fewer
- Patients who have an Hb value <9g/dL at screening
- Patients who received or are scheduled to receive any study drugs in other clinical trials or post-marketing studies within 120 days before screening
- Patients who received or are scheduled to receive medications within seven days before the dosing of the investigational drug
- Patients who previously received administration of Gabapentin or ASP8825
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
- Being tested
- ASP8825
- Keywords
- Impaired renal function, Haemodialysis, ASP8825, XP13512
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8825Drug
Also called gabapentin enacarbil
Oral
| Study group | Role | What they receive |
|---|---|---|
| Renal impairment | Experimental | Not described Receives: Drug: ASP8825 |
| Haemodialysis | Experimental | Not described Receives: Drug: ASP8825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients
Cmax: Maximum concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: tmax in Renal impairment patients
tmax: Time of Cmax
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients
Cmax: Maximum concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
PK parameters of gabapentin in plasma: tmax in Haemodialysis patients
tmax: Time of Cmax
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
PK parameters of gabapentin in plasma: AUClast in Renal impairment patients
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: kel in Renal impairment patients
kel: Elimination rate constant
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients
t1/2: Terminal elimination half-life
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: CL/F in Renal impairment patients
CL/F: Apparent total systemic clearance
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients
Vz/F: Apparent volume of distribution during the terminal elimination phase
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients
t1/2, pre: Elimination half-life for pre-hemodialysis
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing
PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients
t1/2,HD: Elimination half-life for hemodialysis
Measured: 24, 25, 26, 27 and 28 hr after dosing
PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients
t1/2, post: Elimination half-life for post-hemodialysis
Measured: 30, 36 and 48 hr after dosing
PK parameters of gabapentin: CLDP in Haemodialysis patients
CLDP: Hemodialysis clearance calculated from the concentration of gabapentin at pre-dialyzer and post-dialyzer
Measured: 25, 26, 27 and 28 hr after dosing
PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients
AUCD: Area under the concentration-time curve from the start to end of haemodialysis the concentration of gabapentin in plasma pre-dialyzer
Measured: 24, 25, 26, 27 and 28 hr after dosing
PK parameters of gabapentin in urine: Ae72h in Renal impairment patients
Ae72h: Amount of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
Measured: Up to 72 hr after dosing
PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients
Ae%72h: Percent of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
Measured: Up to 72 hr after dosing
PK parameters of gabapentin in urine: CLR in Renal impairment patients
CLR: Renal clearance
Measured: Up to 72 hr after dosing
PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients
Ae48h: Amount of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
Measured: Up to 48 hr after dosing
PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients
Ae%48h: Percent of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
Measured: Up to 48 hr after dosing
PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients
Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing
Measured: Up to 48 hr after dosing
PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients
Adt%: Excretion rate in dialyzing fluid
Measured: Up to 48 hr after dosing
PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients
CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid
Measured: Up to 48 hr after dosing
Safety assessed by AEs
AEs: Adverse Events
Measured: Up to 7 days after the study drug dosing
Safety assessed by Vital signs
Supine blood pressure, supine pulse rate and axillary body temperature
Measured: Up to 7 days after the study drug dosing
Safety assessed by Laboratory tests
Hematology, blood biochemistry, and urinalysis
Measured: Up to 7 days after the study drug dosing
Safety assessed by 12-lead ECGs
ECG: Electrocardiogram
Measured: Up to 7 days after the study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Impaired Renal Function and HaemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629224
- Sponsor's protocol ID
- 8825-CL-0012
- Status last verified
- Feb 2016
- First submitted
- 10 Dec 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis
- ClinicalTrials.gov ID
- NCT02629224
- Acronym / sponsor ID
- 8825-CL-0012
- Keywords
- Impaired renal function, Haemodialysis, ASP8825, XP13512
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal impairment | Experimental | Drug: ASP8825 |
| Haemodialysis | Experimental | Drug: ASP8825 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body weight: ≥40.0 kg and <80.0 kg
- Body mass index BMI: ≥16.0 and <30.0 [BMI= Body weight (kg)/(Height (m))2]
- For Renal impairment patients: Patients with eGFR by GFR predictive equation for Japanese within < 50 mL.min/1.73m2 at screening and who is not undergoing dialysis
- For Haemodialysis patients: Patients who receive dialysis at screening
- Patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to dosing, or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before dosing to follow-up examination in the opinion of the investigator or sub-investigator.
Key exclusion criteria (10 listed)
- Patients with a complication or history of the inappropriate for this study (except for a complication of primary disease for renal dysfunction, like diabetes etc., or complication of hypertension or anemia etc.)
- Patients with a complication or history of recurring alimentary disease
- Patients with a history of gastrointestinal surgical operation
- Patients with a complication of severe heart disease
- Patients with a complication or history of malignant tumor (However, a patient without recurrence of the malignant tumor for more than 5 years after the treatment may be eligible for the study.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8825Also: gabapentin enacarbilOral | Drug | Haemodialysis, Renal impairment |
Primary outcome
Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Cmax: Maximum concentration
PK parameters of gabapentin in plasma: tmax in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
tmax: Time of Cmax
PK parameter of gabapentin in plasma: AUC24h in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
PK parameter of gabapentin in plasma: Cmax in Haemodialysis patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
Cmax: Maximum concentration
PK parameters of gabapentin in plasma: tmax in Haemodialysis patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
tmax: Time of Cmax
PK parameter of gabapentin in plasma: AUC24h in Haemodialysis patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 25, 26, 27, 28, 30, 36 and 48 hr after dosing
AUC24h: Area under the concentration-time curve from the time of dosing to 24hours after dosing
PK parameters of gabapentin in plasma: AUClast in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
AUClast: Area under the concentration-time curve from the time of dosing to the last measurable concentration
PK parameter of gabapentin in plasma: AUCinf in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity
PK parameters of gabapentin in plasma: kel in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
kel: Elimination rate constant
PK parameters of gabapentin in plasma: t1/2 in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
t1/2: Terminal elimination half-life
PK parameters of gabapentin in plasma: CL/F in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
CL/F: Apparent total systemic clearance
PK parameters of gabapentin in plasma: Vz/F in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
Vz/F: Apparent volume of distribution during the terminal elimination phase
PK parameters of gabapentin in plasma: MRTinf in Renal impairment patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing
MRTinf: Mean residence time from the time of dosing extrapolated to time infinity
PK parameters of gabapentin in plasma: t1/2, pre in Haemodialysis patients
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 18 hr after dosing
t1/2, pre: Elimination half-life for pre-hemodialysis
PK parameters of gabapentin in plasma: t1/2, HD in Haemodialysis patients
Time frame: 24, 25, 26, 27 and 28 hr after dosing
t1/2,HD: Elimination half-life for hemodialysis
PK parameters of gabapentin in plasma: t1/2, post in Haemodialysis patients
Time frame: 30, 36 and 48 hr after dosing
t1/2, post: Elimination half-life for post-hemodialysis
PK parameters of gabapentin: CLDP in Haemodialysis patients
Time frame: 25, 26, 27 and 28 hr after dosing
CLDP: Hemodialysis clearance calculated from the concentration of gabapentin at pre-dialyzer and post-dialyzer
PK parameters of gabapentin in plasma: AUCD in Haemodialysis patients
Time frame: 24, 25, 26, 27 and 28 hr after dosing
AUCD: Area under the concentration-time curve from the start to end of haemodialysis the concentration of gabapentin in plasma pre-dialyzer
PK parameters of gabapentin in urine: Ae72h in Renal impairment patients
Time frame: Up to 72 hr after dosing
Ae72h: Amount of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
PK parameters of gabapentin in urine: Ae%72h in Renal impairment patients
Time frame: Up to 72 hr after dosing
Ae%72h: Percent of gabapentin excreted into the urine from the time of dosing to 72 hr after dosing
PK parameters of gabapentin in urine: CLR in Renal impairment patients
Time frame: Up to 72 hr after dosing
CLR: Renal clearance
PK parameters of gabapentin in urine: Ae48h in Haemodialysis patients
Time frame: Up to 48 hr after dosing
Ae48h: Amount of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
PK parameters of gabapentin in urine: Ae%48h in Haemodialysis patients
Time frame: Up to 48 hr after dosing
Ae%48h: Percent of gabapentin excreted into the urine from the time of dosing to 48 hr after dosing
PK parameters of gabapentin in dialyzing fluid: Adt in Haemodialysis patients
Time frame: Up to 48 hr after dosing
Adt: Cumulative amount in dialyzing fluid from the time of dosing to time after dosing
PK parameters of gabapentin in dialyzing fluid: Adt% in Haemodialysis patients
Time frame: Up to 48 hr after dosing
Adt%: Excretion rate in dialyzing fluid
PK parameters of gabapentin in dialyzing fluid: CLDD in Haemodialysis patients
Time frame: Up to 48 hr after dosing
CLDD: Hemodialysis clearance calculated from the Cumulative amount in dialyzing fluid
Safety assessed by AEs
Time frame: Up to 7 days after the study drug dosing
AEs: Adverse Events
Safety assessed by Vital signs
Time frame: Up to 7 days after the study drug dosing
Supine blood pressure, supine pulse rate and axillary body temperature
Safety assessed by Laboratory tests
Time frame: Up to 7 days after the study drug dosing
Hematology, blood biochemistry, and urinalysis
Safety assessed by 12-lead ECGs
Time frame: Up to 7 days after the study drug dosing
ECG: Electrocardiogram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Patients With Impaired Renal Function and Haemodialysis
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Manual Acupuncture for Intradialytic Fatigue in CKD Patients
Intradialytic Fatigue, Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASP8825 in people with Patients With Impaired Renal Function and Haemodialysis, run by Astellas Pharma Inc at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) parameter of gabapentin in plasma: Cmax in Renal impairment patients (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hr after dosing). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.