Hepatic; Functional DisturbancePhase 1NCT01392807
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function
A Phase 1 study testing NKTR-118 in people with Hepatic; Functional Disturbance, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic; Functional Disturbance
- What is being tested?
- NKTR-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive.
- Negative screen for human immunodeficiency virus (HIV)
- For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV
Who cannot join
- Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator.
- Subjects with a history of surgery on the gastrointestinal tract.
- For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function Following Administration of a Single Dose of 25mg NKTR-118
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
- Conditions
- Hepatic; Functional Disturbance
- Being tested
- NKTR-118
- Keywords
- Phase 1, volunteers with hepatic impairment, pharmacokinetics, NKTR-118, Child-Pugh scale, AUC, Cmax, tmax, t1/2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-118Drug
25 mg Oral tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Normal hepatic function, 25 mg NKTR-118 administered orally Receives: Drug: NKTR-118 |
| Group 2 | Experimental | Mild hepatic impairment, 25 mg NKTR-118 administered orally Receives: Drug: NKTR-118 |
| Group 3 | Experimental | Moderate hepatic impairment, 25 mg NKTR-118 administered orally Receives: Drug: NKTR-118 |
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) and maximum concentration (Cmax)
Measured: Duration from predose day 1 to day 6.
Secondary outcomes (3)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events.
Measured: Duration from day -1 to follow up. ( Approximately 15-18 days)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs
Measured: Duration from day -1 to follow up. ( Approximately 15-18 days)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples
Measured: Duration from day -1 to follow up. ( Approximately 15-18 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionNov 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 Hepatic; Functional DisturbanceStudies 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
- 24 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 CenterBo Fransson, MD, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392807
- Sponsor's protocol ID
- D3820C00010
- Status last verified
- Oct 2014
- First submitted
- 8 Jul 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
Publications
Bui K, She F, Sostek M. The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1368-74. doi: 10.1002/jcph.348. Epub 2014 Jun 27.
PubMed 24945932
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, Single-center Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function and Subjects With Normal Hepatic Function Following Administration of a Single Dose of 25mg NKTR-118
- ClinicalTrials.gov ID
- NCT01392807
- Acronym / sponsor ID
- D3820C00010
- Conditions
- Hepatic; Functional Disturbance
- Keywords
- Phase 1, volunteers with hepatic impairment, pharmacokinetics, NKTR-118, Child-Pugh scale, AUC, Cmax, tmax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Jul 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.
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: NKTR-118Normal hepatic function, 25 mg NKTR-118 administered orally |
| Group 2 | Experimental | Drug: NKTR-118Mild hepatic impairment, 25 mg NKTR-118 administered orally |
| Group 3 | Experimental | Drug: NKTR-118Moderate hepatic impairment, 25 mg NKTR-118 administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged 18 years or more with a weight of at least 50 kg and BMI between 18 and 40 kg/m2, inclusive.
- Negative screen for human immunodeficiency virus (HIV)
- For subjects with normal hepatic function, negative results for serum hepatitis B (HBV) surface antigen, HCV antibody, and HIV
Key exclusion criteria (5 listed)
- Plasma or blood product donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
- Known or suspected history of drug/chemical abuse within the past 2 years as judged by the Investigator.
- Subjects with a history of surgery on the gastrointestinal tract.
- For patients with hepatic impairment, fluctuating or rapidly deteriorating hepatic function as indicated by clinical and/or laboratory signs of hepatic impairment (e.g. advanced ascites, infection of ascites, fever, or active gastrointestinal bleeding).
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 |
|---|---|---|
| NKTR-11825 mg Oral tablets, single dose | Drug | Group 1, Group 2, Group 3 |
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) and maximum concentration (Cmax)
Time frame: Duration from predose day 1 to day 6.
3 secondary outcomes
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events.
Time frame: Duration from day -1 to follow up. ( Approximately 15-18 days)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs
Time frame: Duration from day -1 to follow up. ( Approximately 15-18 days)
To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples
Time frame: Duration from day -1 to follow up. ( Approximately 15-18 days)
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 24945932Bui K, She F, Sostek M. The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1368-74. doi: 10.1002/jcph.348. Epub 2014 Jun 27.
- D3820C00010 Clinical Study Report Synopsis.pdfLink 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
Bo Fransson, MD study chair
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NKTR-118 in people with Hepatic; Functional Disturbance, run by AstraZeneca at 1 site 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 3 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 1 site 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) and maximum concentration (Cmax) (time frame: Duration from predose day 1 to day 6.). 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 NCT01392807, 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.