Cytochrome P450 InteractionPhase 1NCT03103646
Study Evaluating the Effect of Multiple Doses of Itraconazole on the Drug Lu AF35700 in Healthy Young Men and Women
A Phase 1 study testing Lu AF35700, Itraconazole (200 mg) and Itraconazole (300 mg) in people with Cytochrome P450 Interaction, run by H. Lundbeck A/S at 2 sites in 2 countries.
Trial summary
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 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
- Cytochrome P450 Interaction
- What is being tested?
- Lu AF35700, Itraconazole (200 mg) and Itraconazole (300 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Mar 2017to 19 Jul 2019
- 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
- Men, aged ≥18 and ≤55 years. body weight ≥50 kg
- women, aged ≥18 and ≤45 years, body weight ≥50 kg
- Good general health as assessed using detailed medical history, laboratory tests, and physical examination
- Known CYP2D6 and CYP2C19 genotype
Who cannot join
- Pregnant or lactating
- Subject has previously been dosed with Lu AF35700
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
- Conditions
- Cytochrome P450 Interaction
- Being tested
- Lu AF35700, Itraconazole (200 mg), Itraconazole (300 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF35700Drug
Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
Itraconazole (200 mg)Drug
100 mg Capsules for oral use, 200 mg/day. In a fed state
Itraconazole (300 mg)Drug
100mg Capsules for oral use, 300 mg/day. In a fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Lu AF35700 | Experimental | Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg Receives: Drug: Lu AF35700 |
| Lu AF35700 AND itraconazole | Experimental | Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole Receives: Drug: Lu AF35700; Drug: Itraconazole (200 mg); Drug: Itraconazole (300 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-inf)
Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Measured: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
Cmax
Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs
Measured: 0-24 hours postdose (Day 1 and day 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start28 Mar 2017
- Primary completion14 Apr 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytochrome P450 InteractionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT03103646
- Sponsor's protocol ID
- 17208A
- Other IDs
- 2016-003302-14, 2016
- Status last verified
- Oct 2019
- First submitted
- 31 Mar 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
- ClinicalTrials.gov ID
- NCT03103646
- Acronym / sponsor ID
- 17208A
- Conditions
- Cytochrome P450 Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- 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.
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AF35700 | Experimental | Drug: Lu AF35700Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg |
| Lu AF35700 AND itraconazole | Experimental | Drug: Lu AF35700, Drug: Itraconazole (200 mg), Drug: Itraconazole (300 mg)Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men, aged ≥18 and ≤55 years. body weight ≥50 kg
- women, aged ≥18 and ≤45 years, body weight ≥50 kg
- Good general health as assessed using detailed medical history, laboratory tests, and physical examination
- Known CYP2D6 and CYP2C19 genotype
Key exclusion criteria (3 listed)
- Pregnant or lactating
- Subject has previously been dosed with Lu AF35700
- Other protocol defined inclusion and exclusion criteria may apply
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 AF35700Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg | Drug | Lu AF35700, Lu AF35700 AND itraconazole |
| Itraconazole (200 mg)100 mg Capsules for oral use, 200 mg/day. In a fed state | Drug | Lu AF35700 AND itraconazole |
| Itraconazole (300 mg)100mg Capsules for oral use, 300 mg/day. In a fasted state. | Drug | Lu AF35700 AND itraconazole |
Primary outcome
AUC(0-inf)
Time frame: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Cmax
Time frame: 0-24 hours postdose (Day 1 and day 32)
Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs
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 2 Oct 2019.
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Interaction
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AF35700, Itraconazole (200 mg) and Itraconazole (300 mg) in people with Cytochrome P450 Interaction, run by H. Lundbeck A/S at 2 sites in 2 countries.
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 4 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
AUC(0-inf) (time frame: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose). 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 2 Oct 2019.