Healthy VolunteersPhase 1NCT02122692
Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
A Phase 1 study testing Lu AE58054 30 mg, Lu AE58054 30 mg + itraconazole 200 mg and Itraconazole in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in France.
Trial summary
To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lu AE58054 30 mg, Lu AE58054 30 mg + itraconazole 200 mg 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 siteFrance
- Study dates
- Mar 2014to Jun 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are eligible for inclusion into the study if they meet each of the following criteria:
- Men and women, aged 18 - 45 years.
- Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
- Non-childbearing potential or use of contraception (both sexes).
- Women must not be pregnant or lactating.
- Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .
- Other 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, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).
- Conditions
- Healthy Volunteers
- Being tested
- Lu AE58054 30 mg, Lu AE58054 30 mg + itraconazole 200 mg, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AE58054 30 mgDrug
Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
Lu AE58054 30 mg + itraconazole 200 mgDrug
Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
ItraconazoleDrug
Itraconazole capsules, once daily, Day 12-13, orally
| Study group | Role | What they receive |
|---|---|---|
| Lu AE58054 30 mg + itraconazole 200 mg | Experimental | Not described Receives: Drug: Lu AE58054 30 mg; Drug: Lu AE58054 30 mg + itraconazole 200 mg; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Measured: Day 5 and Day 11
Maximum observed concentration (Cmax) of Lu AE58054
Measured: Day 5 and Day 11
Secondary outcomes (5)
Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F
Measured: Day 5 and Day 11
Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)
Measured: Day 5 and Day 11
Plasma pharmacokinetic parameters for itraconazole: CTrough
Measured: Day 6 to Day 13
Adverse events
Measured: Up to Day 18, including a safety follow-up
Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions
Measured: Up to Day 18, including a safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
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 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
- Not applicable
- Intervention model
- Single group
- 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
- NCT02122692
- Sponsor's protocol ID
- 15820A
- Other IDs
- 2013-003597-27
- Status last verified
- Jun 2014
- First submitted
- 23 Apr 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02122692
- Acronym / sponsor ID
- 15820A
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- First posted
- 24 Apr 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.
To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AE58054 30 mg + itraconazole 200 mg | Experimental | Drug: Lu AE58054 30 mg, Drug: Lu AE58054 30 mg + itraconazole 200 mg, Drug: Itraconazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects are eligible for inclusion into the study if they meet each of the following criteria:
- Men and women, aged 18 - 45 years.
- Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
- Non-childbearing potential or use of contraception (both sexes).
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 AE58054 30 mgLu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally | Drug | Lu AE58054 30 mg + itraconazole 200 mg |
| Lu AE58054 30 mg + itraconazole 200 mgLu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally | Drug | Lu AE58054 30 mg + itraconazole 200 mg |
| ItraconazoleItraconazole capsules, once daily, Day 12-13, orally | Drug | Lu AE58054 30 mg + itraconazole 200 mg |
Primary outcome
Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
Time frame: Day 5 and Day 11
Maximum observed concentration (Cmax) of Lu AE58054
Time frame: Day 5 and Day 11
5 secondary outcomes
Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F
Time frame: Day 5 and Day 11
Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)
Time frame: Day 5 and Day 11
Plasma pharmacokinetic parameters for itraconazole: CTrough
Time frame: Day 6 to Day 13
Adverse events
Time frame: Up to Day 18, including a safety follow-up
Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions
Time frame: Up to Day 18, including a safety follow-up
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 19 Jun 2014.
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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 AE58054 30 mg, Lu AE58054 30 mg + itraconazole 200 mg and Itraconazole in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in France.
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 8 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 19 Jun 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 France. 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 AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24) (time frame: Day 5 and Day 11). 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 19 Jun 2014.