HealthyPhase 1NCT04082325
Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men
A Phase 1 study testing Lu AF88434, Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) and Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
Trial summary
This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AF88434, Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) and Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Jul 2019to 24 Sep 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Healthy young non-smoking men with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.
Who cannot join
- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- For Part B: The subject has received radiolabelled material <12 months prior to the Screening Visit.
- Other inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Properties of Lu AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men
This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses
- Conditions
- Healthy
- Being tested
- Lu AF88434, Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434), Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF88434Drug
Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)Drug
Oral solution
Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)Drug
Oral solution
PlaceboDrug
Placebo to Lu AF88434 oral solution, single dose
| Study group | Role | What they receive |
|---|---|---|
| Part A Lu AF88434 or Placebo | Experimental | 6 cohorts (cohort A1 to A6) with 9 subjects in each cohort. In each cohort 6 subjects will receive single doses of Lu AF88434 and 3 subjects will receive placebo Receives: Drug: Lu AF88434; Drug: Placebo |
| Part B1 Lu AF88434 Fed-Fasting-Fasting | Experimental | 4 subjects will receive an identical oral dose of Lu AF88434 in Group B1. The treatment sequence for Group B1 is: Fed-Fasting-Fasting. 14C-spiked dose (Lu AF99723) will be given in the last treatment sequence. Receives: Drug: Lu AF88434; Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) |
| Part B2 Lu AF88434 Fasting-Fed-Fasting | Experimental | 4 subjects will receive an identical oral dose of Lu AF88434 in Group B2. The treatment sequence for Group B2 is: Fasting-Fed-Fasting. 14C-spiked dose (Lu AF99722) will be given in the last treatment sequence. Receives: Drug: Lu AF88434; Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) |
| Part B3 Lu AF88434 Fasting-Fasting-Fed | Experimental | 4 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed. Receives: Drug: Lu AF88434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters)
Measured: From screening to Day 11
Cmax Lu AF88434
Maximum observed plasma concentration
Measured: From 0 to 96 hours
AUC(0-inf) Lu AF88434
Area under the plasma concentration time curve from zero to infinity
Measured: From 0 to 96 hours
CL/F Lu AF88434
Oral clearance for Lu AF88434 in plasma
Measured: From day 1 to day 5
Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Measured: From 0 to Day 14
Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Measured: From 0 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start23 Jul 2019
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 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
- NCT04082325
- Sponsor's protocol ID
- 18144A
- Status last verified
- Feb 2021
- First submitted
- 5 Sep 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Properties of Lu AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men
- ClinicalTrials.gov ID
- NCT04082325
- Acronym / sponsor ID
- 18144A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 9 Sep 2019 (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 evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Lu AF88434 or Placebo | Experimental | Drug: Lu AF88434, Drug: Placebo6 cohorts (cohort A1 to A6) with 9 subjects in each cohort. In each cohort 6 subjects will receive single doses of Lu AF88434 and 3 subjects will receive placebo |
| Part B1 Lu AF88434 Fed-Fasting-Fasting | Experimental | Drug: Lu AF88434, Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)4 subjects will receive an identical oral dose of Lu AF88434 in Group B1. The treatment sequence for Group B1 is: Fed-Fasting-Fasting. 14C-spiked dose (Lu AF99723) will be given in the last treatment sequence. |
| Part B2 Lu AF88434 Fasting-Fed-Fasting | Experimental | Drug: Lu AF88434, Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)4 subjects will receive an identical oral dose of Lu AF88434 in Group B2. The treatment sequence for Group B2 is: Fasting-Fed-Fasting. 14C-spiked dose (Lu AF99722) will be given in the last treatment sequence. |
| Part B3 Lu AF88434 Fasting-Fasting-Fed | Experimental | Drug: Lu AF884344 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Healthy young non-smoking men with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline Visit.
Key exclusion criteria (3 listed)
- The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
- For Part B: The subject has received radiolabelled material <12 months prior to the Screening Visit.
- Other 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 AF88434Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s). | Drug | Part A Lu AF88434 or Placebo, Part B1 Lu AF88434 Fed-Fasting-Fasting, Part B2 Lu AF88434 Fasting-Fed-Fasting, Part B3 Lu AF88434 Fasting-Fasting-Fed |
| Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)Oral solution | Drug | Part B2 Lu AF88434 Fasting-Fed-Fasting |
| Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)Oral solution | Drug | Part B1 Lu AF88434 Fed-Fasting-Fasting |
| PlaceboPlacebo to Lu AF88434 oral solution, single dose | Drug | Part A Lu AF88434 or Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: From screening to Day 11
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters)
Cmax Lu AF88434
Time frame: From 0 to 96 hours
Maximum observed plasma concentration
AUC(0-inf) Lu AF88434
Time frame: From 0 to 96 hours
Area under the plasma concentration time curve from zero to infinity
CL/F Lu AF88434
Time frame: From day 1 to day 5
Oral clearance for Lu AF88434 in plasma
Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Time frame: From 0 to Day 14
Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)
Time frame: From 0 to Day 14
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 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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 AF88434, Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434) and Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434) in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
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 1 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 24 Feb 2021. 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 Netherlands. 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?
Number of participants with treatment-emergent adverse events (time frame: From screening to Day 11). The study lists 6 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 24 Feb 2021.