Healthy VolunteersPhase 1NCT01348724
Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] NKTR-118
A Phase 1 study testing [14C] NKTR-118 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration. Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C] NKTR-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Sep 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 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and a minimum weight of 50 kg
- Regular daily bowel movements (ie, production of at least 1 stool per day).
- Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1
Who cannot join
- Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
- Participation in any prior radiolabelled study within 12 months of screening visit 1
- Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After [14C]-Labelled Oral Administration of NKTR-118 to Healthy Male Volunteers
Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration.
- Conditions
- Healthy Volunteers
- Being tested
- [14C] NKTR-118
- Keywords
- Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] NKTR-118Drug
Single 25 mg oral dose administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| [14C] NKTR-118 | Experimental | Not described Receives: Drug: [14C] NKTR-118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces
Measured: Range of Day 1 until day 10
Concentration of total radioactivity in blood and plasma samples
Measured: Range of Day 1 until day 10
Concentration of NKTR-118 in blood and plasma sample
Measured: Range of Day 1 until day 10
Secondary outcomes (3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples
Measured: Range of Day -1 until follow up visit (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Kasti, MD, Principal investigator, Quintiles, Inc.Mark Sostek, PhD, Study director, AstraZenecaEmeline Ramos, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348724
- Sponsor's protocol ID
- D3820C00001
- Status last verified
- Oct 2014
- First submitted
- 21 Apr 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
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
- A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After [14C]-Labelled Oral Administration of NKTR-118 to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01348724
- Acronym / sponsor ID
- D3820C00001
- Conditions
- Healthy Volunteers
- Keywords
- Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 May 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.
Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] NKTR-118 | Experimental | Drug: [14C] NKTR-118 |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and a minimum weight of 50 kg
- Regular daily bowel movements (ie, production of at least 1 stool per day).
- Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1
Key exclusion criteria (3 listed)
- Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
- Participation in any prior radiolabelled study within 12 months of screening visit 1
- Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day
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 |
|---|---|---|
| [14C] NKTR-118Single 25 mg oral dose administered on Day 1 | Drug | [14C] NKTR-118 |
Primary outcome
Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces
Time frame: Range of Day 1 until day 10
Concentration of total radioactivity in blood and plasma samples
Time frame: Range of Day 1 until day 10
Concentration of NKTR-118 in blood and plasma sample
Time frame: Range of Day 1 until day 10
3 secondary outcomes
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples
Time frame: Range of Day -1 until follow up visit (Visit 3)
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.
- 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.
Marianne Kasti, MD principal investigator
Quintiles, Inc.
Mark Sostek, PhD study director
AstraZeneca
Emeline Ramos 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 [14C] NKTR-118 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
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 3 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 Kingdom. 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?
Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces (time frame: Range of Day 1 until day 10). The study lists 3 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 15 Oct 2014.