Renal ImpairmentPhase 1NCT01372826
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
A Phase 1 study testing NKTR118 Group1, NKTR118 Group 2 and NKTR118 Group3 in people with Renal Impairment, run by AstraZeneca at 3 sites in United States.
Trial summary
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- NKTR118 Group1, NKTR118 Group 2 and NKTR118 Group3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to Nov 2011
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed written and dated informed consent prior to any study specific procedures.
- Male or female volunteers aged 18 to 80 years (inclusive) having normal renal function, or suffering from moderate or severe renal impairment or ESRD.
- Male subjects who are sexually active must be willing to use a barrier method of contraception (condom). Women must be of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test (at screening and at each admission) and be using a highly effective form of birth control for 3 months before enrollment and be willing to use a highly effective form of birth control during the study and until 3 months after their last dose of IP.
- Have a BMI between 18 and 40 kg/m2 (inclusive) and weigh at least 50 kg.
- Subjects must be able to understand and to comply with study procedures, restrictions and requirements.
Who cannot join
- History of any clinically significant medical history which, in the opinion of the Investigator and Sponsor, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
- History or presence of gastrointestinal hepatic or other condition known to interfere with disposition of the study drug (except for renal function impairment).
- Subjects who have a functioning kidney transplant.
- Acute illness, surgical procedures or trauma from within 2 weeks before enrollment until first administration of study drug
- Known or suspected history of drug abuse as judged by the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Anaheim, California
Research Site
Orlando, Florida
Research Site
Overland Park, Kansas
About this study
Official title: An Open-Label, Parallel-Group, Phase I Study to Compare the Pharmacokinetics of NKTR-118 Following a Single Oral Dose in Subjects With Renal Impairment and Subjects With Normal Renal Function
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
- Conditions
- Renal Impairment
- Being tested
- NKTR118 Group1, NKTR118 Group 2, NKTR118 Group3, NKTR118
- Keywords
- Phase 1, Pharmacokinetics, NKTR-118, renal impairment, parallel study, QTcF Interval, AUC(0-t), Cmax, tmax
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR118 Group1Drug
Oral dose, 25 mg
NKTR118 Group 2Drug
Oral dose, 25 mg
NKTR118 Group3Drug
Oral dose, 25 mg
NKTR118Drug
Oral dose, 25 mg
| Study group | Role | What they receive |
|---|---|---|
| NKTR118 Group1 | Experimental | Normal Renal Function Receives: Drug: NKTR118 Group1 |
| NKTR118 Group 2 | Experimental | Moderate Renal Function Receives: Drug: NKTR118 Group 2 |
| NKTR118 Group 3 | Experimental | Severe Renal Impairment Receives: Drug: NKTR118 Group3 |
| NKTR118 Group 4 | Experimental | End-Stage Renal Disease Receives: Drug: NKTR118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC)
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
Measured: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax)
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
Measured: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.
Secondary outcomes (3)
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events.
Measured: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs
Measured: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples
Measured: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sostek, MD, Study director, AstraZenecaThomas Marbury, MD, Principal investigator, Orlando Clinical Research Center US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372826
- Sponsor's protocol ID
- D3820C00009
- Status last verified
- Oct 2014
- First submitted
- 25 May 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bui K, She F, Sostek M. The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1375-82. doi: 10.1002/jcph.349. Epub 2014 Jul 1.
PubMed 24946021
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Group, Phase I Study to Compare the Pharmacokinetics of NKTR-118 Following a Single Oral Dose in Subjects With Renal Impairment and Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT01372826
- Acronym / sponsor ID
- D3820C00009
- Conditions
- Renal Impairment
- Keywords
- Phase 1, Pharmacokinetics, NKTR-118, renal impairment, parallel study, QTcF Interval, AUC(0-t), Cmax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Jun 2011 (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.
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NKTR118 Group1 | Experimental | Drug: NKTR118 Group1Normal Renal Function |
| NKTR118 Group 2 | Experimental | Drug: NKTR118 Group 2Moderate Renal Function |
| NKTR118 Group 3 | Experimental | Drug: NKTR118 Group3Severe Renal Impairment |
| NKTR118 Group 4 | Experimental | Drug: NKTR118End-Stage Renal Disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed written and dated informed consent prior to any study specific procedures.
- Male or female volunteers aged 18 to 80 years (inclusive) having normal renal function, or suffering from moderate or severe renal impairment or ESRD.
- Male subjects who are sexually active must be willing to use a barrier method of contraception (condom). Women must be of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test (at screening and at each admission) and be using a highly effective form of birth control for 3 months before enrollment and be willing to use a highly effective form of birth control during the study and until 3 months after their last dose of IP.
- Have a BMI between 18 and 40 kg/m2 (inclusive) and weigh at least 50 kg.
- Subjects must be able to understand and to comply with study procedures, restrictions and requirements.
Key exclusion criteria (5 listed)
- History of any clinically significant medical history which, in the opinion of the Investigator and Sponsor, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.
- History or presence of gastrointestinal hepatic or other condition known to interfere with disposition of the study drug (except for renal function impairment).
- Subjects who have a functioning kidney transplant.
- Acute illness, surgical procedures or trauma from within 2 weeks before enrollment until first administration of study drug
- Known or suspected history of drug abuse as judged by the Investigator.
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 |
|---|---|---|
| NKTR118 Group1Oral dose, 25 mg | Drug | NKTR118 Group1 |
| NKTR118 Group 2Oral dose, 25 mg | Drug | NKTR118 Group 2 |
| NKTR118 Group3Oral dose, 25 mg | Drug | NKTR118 Group 3 |
| NKTR118Oral dose, 25 mg | Drug | NKTR118 Group 4 |
Primary outcome
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC)
Time frame: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax)
Time frame: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.
Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis)
3 secondary outcomes
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events.
Time frame: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs
Time frame: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples
Time frame: Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment
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 15 Oct 2014.
- Derived from this study: PubMed 24946021Bui K, She F, Sostek M. The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1375-82. doi: 10.1002/jcph.349. Epub 2014 Jul 1.
- D3820C00009 Clinical Study Report SynopsisLink provided by the sponsor.
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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.
Mark Sostek, MD study director
AstraZeneca
Thomas Marbury, MD principal investigator
Orlando Clinical Research Center US
3 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 NKTR118 Group1, NKTR118 Group 2 and NKTR118 Group3 in people with Renal Impairment, run by AstraZeneca at 3 sites in United States.
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 5 inclusion and 5 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) (time frame: PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01372826, which also lists 1 linked publication.
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 15 Oct 2014.