HealthyPhase 1NCT02199431
Study to Evaluate the Effect of a Known and Marketed Product, Itraconazole (Mycosis Treatment) on Lu AF11167 Entering the Body and Subsequently Elimination. The Study is a Drug-drug Interaction Study in Healthy Volunteers.
A Phase 1 study testing Lu AF11167 and Itraconazole in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers 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?
- Lu AF11167 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Feb 2015
- 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
- Subjects be 18 years of age and 55 years of age and with a BMI >18.5 kg/m2 and <30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.
- Other pre-defined inclusion and exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects
The purpose of this study is to evaluate the increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers
- Conditions
- Healthy
- Being tested
- Lu AF11167, Itraconazole
- Keywords
- Lu AF11167, Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF11167Drug
ItraconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Lu AF1167 capsule 0.5 mg | Experimental | Single oral dose (day 1) Receives: Drug: Lu AF11167 |
| Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule | Experimental | Itraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8 Receives: Drug: Lu AF11167; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)
Measured: Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF11167
Measured: Day 1 and 8
Secondary outcomes (2)
Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)
Measured: Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF36201
Measured: Day 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
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 H. Lundbeck A/SThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199431
- Sponsor's protocol ID
- 14380A
- Other IDs
- 2013-003870-28
- Status last verified
- Sep 2015
- First submitted
- 23 Jul 2014
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Interaction Study Investigating the Effects of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics and Safety and Tolerability of Lu AF11167 in Healthy Young Subjects
- ClinicalTrials.gov ID
- NCT02199431
- Acronym / sponsor ID
- 14380A
- Conditions
- Healthy
- Keywords
- Lu AF11167, Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- First posted
- 24 Jul 2014 (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 increase in exposure of Lu AF11167 following a single oral dose of Lu AF11167 with and without administration of multiple oral doses of itraconazole (a strong CYP3A4/5 inhibitor) in healthy subjects with inferred metabolic status as CYP2C19 extensive metabolisers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AF1167 capsule 0.5 mg | Experimental | Drug: Lu AF11167Single oral dose (day 1) |
| Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule | Experimental | Drug: Lu AF11167, Drug: ItraconazoleItraconazole administered once daily for 7 days (day 3-9); Lu AF11167 administered as a single dose on day 8 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects be 18 years of age and 55 years of age and with a BMI >18.5 kg/m2 and <30.0 kg/m2 at the Screening Visit. Women must not be pregnant or lactating.
- Other pre-defined inclusion and exclusion criteria may apply.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lu AF11167 | Drug | Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule, Lu AF1167 capsule 0.5 mg |
| Itraconazole | Drug | Lu AF11167 0.5 mg capsule + itraconazole 200 mg capsule |
Primary outcome
Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF11167
Time frame: Day 1 and 8
2 secondary outcomes
Area under the Lu AF36201 plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Day 1 and 8
Maximum observed plasma concentration (Cmax) of Lu AF36201
Time frame: Day 1 and 8
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 21 Sep 2015.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
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 Lu AF11167 and Itraconazole in people with Healthy, run by H. Lundbeck A/S 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 2 inclusion and 0 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 21 Sep 2015. 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?
Area under the Lu AF11167 plasma concentration-time curve from zero to infinity (AUC0-inf) (time frame: Day 1 and 8). 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?
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 21 Sep 2015.