HealthyPhase 1NCT01365000
Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects
A Phase 1 study testing NKTR118 Formulation 1, NKTR118 Formulation 2 and NKTR118 Formulation 3 in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NKTR118 Formulation 1, NKTR118 Formulation 2 and NKTR118 Formulation 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Aug 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study-specific procedures
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range
- Irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
- Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
- Volunteers must be able to understand and be willing to comply with study procedures, restrictions and requirements
- Healthy male and non-fertile female volunteers ages 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture
Who cannot join
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the absorption, distribution, metabolism, and excretion of drugs
- Current smokers, those who have smoked or used nicotine products within the previous 3 months from the date of screening (Visit 1)
- Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening or intention to donate blood or blood products during the study or within 3 months after the completion of the study
- Positive screen for drugs of abuse, or cotinine (nicotine level above 400 ng/mL), at screening or admission and/or positive alcohol test at admission
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Randomized, Balanced, Single-dose, Two-Part Study to Assess the Relative Bioavailability of NKTR-118 in Three Formulations Under Fasted (3-Way Crossover) and Fed (2-Way Crossover) Conditions in Male and Non-fertile Female Subjects
The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.
- Conditions
- Healthy
- Being tested
- NKTR118 Formulation 1, NKTR118 Formulation 2, NKTR118 Formulation 3, NKTR118 Formulation 1a, NKTR118 Formulation 3a
- Keywords
- Phase 1, Pharmacokinetics, NKTR-118, fasting or fed state, cross-over study, AUC(0-t), Cmax, tmax, QTcF Interval
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR118 Formulation 1Drug
Oral dose, 25 mg
NKTR118 Formulation 2Drug
Oral dose, 25 mg
NKTR118 Formulation 3Drug
Oral dose, 25 mg
NKTR118 Formulation 1aDrug
Oral dose, 25 mg
NKTR118 Formulation 3aDrug
Oral dose, 25 mg
| Study group | Role | What they receive |
|---|---|---|
| NKTR118 Formulation 1 | Experimental | Fasted Receives: Drug: NKTR118 Formulation 1 |
| NKTR118 Formulation 2 | Experimental | Fasted Receives: Drug: NKTR118 Formulation 2 |
| NKTR118 Formulation 3 | Experimental | Fasted Receives: Drug: NKTR118 Formulation 3 |
| NKTR118 Formulation 1a | Experimental | Fed Receives: Drug: NKTR118 Formulation 1a |
| NKTR118 Formulation 3a | Experimental | FED Receives: Drug: NKTR118 Formulation 3a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)
Measured: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax)
Measured: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz)
Measured: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t))
Measured: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC).
Measured: day-1 to day 3
Secondary outcomes (5)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events
Measured: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values
Measured: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms
Measured: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Duration day -1 (Visit 2) to follow up (Visit 12)
Concentration of NKTR-118 in plasma samples after drug intake during Fed condition
Measured: Duration: Day 1 to day 4 at the 2 last inhouse stays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Sostek, MD, Study director, AstraZenecaDavid Mathews, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365000
- Sponsor's protocol ID
- D3820C00025
- Status last verified
- Oct 2014
- First submitted
- 31 May 2011
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- 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, Randomized, Balanced, Single-dose, Two-Part Study to Assess the Relative Bioavailability of NKTR-118 in Three Formulations Under Fasted (3-Way Crossover) and Fed (2-Way Crossover) Conditions in Male and Non-fertile Female Subjects
- ClinicalTrials.gov ID
- NCT01365000
- Acronym / sponsor ID
- D3820C00025
- Conditions
- Healthy
- Keywords
- Phase 1, Pharmacokinetics, NKTR-118, fasting or fed state, cross-over study, AUC(0-t), Cmax, tmax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 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.
The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NKTR118 Formulation 1 | Experimental | Drug: NKTR118 Formulation 1Fasted |
| NKTR118 Formulation 2 | Experimental | Drug: NKTR118 Formulation 2Fasted |
| NKTR118 Formulation 3 | Experimental | Drug: NKTR118 Formulation 3Fasted |
| NKTR118 Formulation 1a | Experimental | Drug: NKTR118 Formulation 1aFed |
| NKTR118 Formulation 3a | Experimental | Drug: NKTR118 Formulation 3aFED |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Post-menopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range
- Irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
- Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
Key exclusion criteria (5 listed)
- Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the absorption, distribution, metabolism, and excretion of drugs
- Current smokers, those who have smoked or used nicotine products within the previous 3 months from the date of screening (Visit 1)
- Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening or intention to donate blood or blood products during the study or within 3 months after the completion of the study
- Positive screen for drugs of abuse, or cotinine (nicotine level above 400 ng/mL), at screening or admission and/or positive alcohol test at admission
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
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 Formulation 1Oral dose, 25 mg | Drug | NKTR118 Formulation 1 |
| NKTR118 Formulation 2Oral dose, 25 mg | Drug | NKTR118 Formulation 2 |
| NKTR118 Formulation 3Oral dose, 25 mg | Drug | NKTR118 Formulation 3 |
| NKTR118 Formulation 1aOral dose, 25 mg | Drug | NKTR118 Formulation 1a |
| NKTR118 Formulation 3aOral dose, 25 mg | Drug | NKTR118 Formulation 3a |
Primary outcome
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax)
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax)
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz)
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t))
Time frame: day-1 to day 3
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC).
Time frame: day-1 to day 3
5 secondary outcomes
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Duration day -1 (Visit 2) to follow up (Visit 12)
Concentration of NKTR-118 in plasma samples after drug intake during Fed condition
Time frame: Duration: Day 1 to day 4 at the 2 last inhouse stays
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.
- D3820C00025 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
David Mathews, MD principal investigator
Quintiles, Inc.
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 NKTR118 Formulation 1, NKTR118 Formulation 2 and NKTR118 Formulation 3 in people with Healthy, 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 7 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?
Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax) (time frame: day-1 to day 3). The study lists 5 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.