Amount of NKTR-118 in BloodPhase 1NCT01325415
A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects
A Phase 1 study testing NKTR-118 and moxifloxacin in people with Amount of NKTR-118 in Blood and Variation in the Heart's Electrical Cycle, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects on QTc interval in healthy males when administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a specific time interval that can be measured in a heart beat by taking Electrocardiogram (ECG)) Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Amount of NKTR-118 in Blood, Variation in the Heart's Electrical Cycle
- What is being tested?
- NKTR-118 and moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weight at least 50 kg but no more than 100 kg.
Who cannot join
- Clinically significant medical history including severe allergies or a history of mental disorders or any cardiac history, history or presence of gastrointestinal, hepatic, or renal disease.
- Abnormal heart rhythm including any abnormal arrhythmias, marked sinus arrhythmias, or junctional rhythms.
- Known or suspected history of drug abuse, current smokers or those who have smoked and/or used nicotine products within 3 months prior to enrollment.
- Excessive intake of caffeine-containing products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label, Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects
The purpose of this study is to evaluate the effects on QTc interval in healthy males when administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a specific time interval that can be measured in a heart beat by taking Electrocardiogram (ECG))
Read the detailed description
A Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label, Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
- Being tested
- NKTR-118, moxifloxacin, Placebo
- Keywords
- Phase 1, healthy male volunteers, cross-over study, NKTR-118
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-118Drug
25 mg tablet
moxifloxacinDrug
400 mg tablet
PlaceboDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets) Receives: Drug: NKTR-118; Drug: Placebo |
| B | Experimental | NKTR-118 150 mg (6x25 mg tablet) Receives: Drug: NKTR-118; Drug: Placebo |
| C | Placebo comparator | NKTR-118 placebo (6x placebo tablets) Receives: Drug: Placebo |
| D | Active comparator | Moxifloxacin (1 x 400 mg tablet) Receives: Drug: moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo
Measured: 30 days pre-dose through 4 treatment periods and follow up 71 days post dose.
The effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo
Measured: Follow up 71 days post dose.
Secondary outcomes (4)
To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data.
Measured: 30 days pre-dose through 4 treatment periods
Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects.
Measured: 30 days pre-dose through 4 treatment periods
To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data.
Measured: Follow up 71 days post dose
Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects.
Measured: Follow up 71 days post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 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 Amount of NKTR-118 in BloodStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sostek, MD, Study director, AstraZeneca, Wilmington USDavid Matthews, MD, Principal investigator, Quintiles, Overland Park Kansas USEmilie Ramos, MD, Study chair, AstraZeneca, Alderley Park, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325415
- Sponsor's protocol ID
- D3820C00014
- Status last verified
- Oct 2014
- First submitted
- 28 Mar 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gottfridsson C, Carlson G, Lappalainen J, Sostek M. Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers. Clin Ther. 2013 Dec;35(12):1876-83. doi: 10.1016/j.clinthera.2013.09.019. Epub 2013 Nov 13.
PubMed 24238792
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 Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label, Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01325415
- Acronym / sponsor ID
- D3820C00014
- Keywords
- Phase 1, healthy male volunteers, cross-over study, NKTR-118
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Mar 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 evaluate the effects on QTc interval in healthy males when administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a specific time interval that can be measured in a heart beat by taking Electrocardiogram (ECG))
Detailed description
A Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label, Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NKTR-118, Drug: PlaceboNKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets) |
| B | Experimental | Drug: NKTR-118, Drug: PlaceboNKTR-118 150 mg (6x25 mg tablet) |
| C | Placebo comparator | Drug: PlaceboNKTR-118 placebo (6x placebo tablets) |
| D | Active comparator | Drug: moxifloxacinMoxifloxacin (1 x 400 mg tablet) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weight at least 50 kg but no more than 100 kg.
Key exclusion criteria (4 listed)
- Clinically significant medical history including severe allergies or a history of mental disorders or any cardiac history, history or presence of gastrointestinal, hepatic, or renal disease.
- Abnormal heart rhythm including any abnormal arrhythmias, marked sinus arrhythmias, or junctional rhythms.
- Known or suspected history of drug abuse, current smokers or those who have smoked and/or used nicotine products within 3 months prior to enrollment.
- Excessive intake of caffeine-containing products
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 tablet | Drug | A, B |
| moxifloxacin400 mg tablet | Drug | D |
| Placebotablet | Drug | A, B, C |
Primary outcome
To evaluate the effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo
Time frame: 30 days pre-dose through 4 treatment periods and follow up 71 days post dose.
The effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo
Time frame: Follow up 71 days post dose.
4 secondary outcomes
To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data.
Time frame: 30 days pre-dose through 4 treatment periods
Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects.
Time frame: 30 days pre-dose through 4 treatment periods
To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data.
Time frame: Follow up 71 days post dose
Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects.
Time frame: Follow up 71 days post dose.
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 24238792Gottfridsson C, Carlson G, Lappalainen J, Sostek M. Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers. Clin Ther. 2013 Dec;35(12):1876-83. doi: 10.1016/j.clinthera.2013.09.019. Epub 2013 Nov 13.
- D3820C00014 Clinical Study Report SynopsisLink provided by the sponsor.
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, Wilmington US
David Matthews, MD principal investigator
Quintiles, Overland Park Kansas US
Emilie Ramos, MD study chair
AstraZeneca, Alderley Park, UK
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 and moxifloxacin in people with Amount of NKTR-118 in Blood and Variation in the Heart's Electrical Cycle, 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 2 inclusion and 4 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. Some participants in this study may receive a placebo. 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 evaluate the effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo (time frame: 30 days pre-dose through 4 treatment periods and follow up 71 days 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 NCT01325415, 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.