Drug ReactionsPhase 1NCT03195946
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
A Phase 1 study testing Lu AF35700, Midazolam and Cocktail of CYP450 substrates in people with Drug Reactions, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
This study will help determine which types of drugs that may interact with Lu AF35700 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Reactions
- What is being tested?
- Lu AF35700, Midazolam and Cocktail of CYP450 substrates
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2017to 3 Jan 2018
- 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
- Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination
Who cannot join
- -Pregnant or lactating women
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults
This study will help determine which types of drugs that may interact with Lu AF35700
- Conditions
- Drug Reactions
- Being tested
- Lu AF35700, Midazolam, Cocktail of CYP450 substrates
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
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, 10 mg/day
MidazolamDrug
syrup for oral use, 4mg/day
Cocktail of CYP450 substratesDrug
Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Lu AF35700 and Cocktail of CYP450 substrates | Experimental | Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail Receives: Drug: Lu AF35700; Drug: Midazolam; Drug: Cocktail of CYP450 substrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity
Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites
Measured: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.
Cmax: Maximum observed concentration
Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites
Measured: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start16 Jun 2017
- Primary completion3 Jan 2018
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ReactionsStudies 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
- 24 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
- NCT03195946
- Sponsor's protocol ID
- 17200A
- Other IDs
- 2016-003187-39, 2016
- Status last verified
- Jan 2018
- First submitted
- 20 Jun 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT03195946
- Acronym / sponsor ID
- 17200A
- Conditions
- Drug Reactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 22 Jun 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 help determine which types of drugs that may interact with Lu AF35700
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF35700 and Cocktail of CYP450 substrates | Experimental | Drug: Lu AF35700, Drug: Midazolam, Drug: Cocktail of CYP450 substratesDay 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2
- Good general health ascertained by a detailed medical history, laboratory tests and physical examination
Key exclusion criteria (2 listed)
- -Pregnant or lactating women
- 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, 10 mg/day | Drug | Lu AF35700 and Cocktail of CYP450 substrates |
| Midazolamsyrup for oral use, 4mg/day | Drug | Lu AF35700 and Cocktail of CYP450 substrates |
| Cocktail of CYP450 substratesCaffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day | Drug | Lu AF35700 and Cocktail of CYP450 substrates |
Primary outcome
AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity
Time frame: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.
Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites
Cmax: Maximum observed concentration
Time frame: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.
Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites
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 8 Jan 2018.
- Individual participant dataSharing planned: No
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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 AF35700, Midazolam and Cocktail of CYP450 substrates in people with Drug Reactions, 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 2 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 8 Jan 2018. 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?
AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity (time frame: Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.). 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 8 Jan 2018.