HealthyPhase 1NCT04199585
Safety and Tolerability of Lu AF95245 in Healthy Young Men
A Phase 1 study testing Lu AF95245 and Lu AF95245 14C radiolabelled spiked dosage in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug 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 AF95245 and Lu AF95245 14C radiolabelled spiked dosage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2019to 19 Feb 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) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
Who cannot join
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.
- Other in- 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 AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men
The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug
Read the detailed description
The study is divided in two parts, Part A and Part B:
Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men.
Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3)
Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.
- Conditions
- Healthy
- Being tested
- Lu AF95245, Lu AF95245 14C radiolabelled spiked dosage, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF95245Drug
solution, single dose, orally
Lu AF95245 14C radiolabelled spiked dosageDrug
solution, single dose, orally
PlaceboDrug
solution, single dose, orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: single-ascending oral dose | Experimental | Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential Receives: Drug: Lu AF95245; Drug: Placebo |
| Cohort B: (fasting/fed conditions) | Experimental | Groups B1, B2, and B3, with 4 subjects in each group and the groups will be running in parallel.
B1: fed-fasting-fasting condition (spiked dosage)
B2: fasting-fed-fasting condition (spiked dosage)
B3: fasting-fasting-fed condition Receives: Drug: Lu AF95245; Drug: Lu AF95245 14C radiolabelled spiked dosage |
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 and physical examination)
Measured: From baseline to Day 14
AUC(0-inf) Lu AF95245
Area under the plasma concentration time curve from zero to infinity
Measured: From 0 to 96 hours
Cmax Lu AF95245
Maximum observed plasma concentration
Measured: From 0 to 96 hours
CL/F Lu AF95245
Oral clearance for Lu AF95245 in plasma
Measured: From 0 to 96 hours
Total recovery of the administered dose (% of dose in urine and faeces)
Excretion of labelled Lu AF95245 in urine and faeces
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 posted16 Dec 2019
- Study start10 Dec 2019
- Primary completion16 Feb 2020
- Study completion19 Feb 2020
Why it stopped: new safety data from another study
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
- Model description
- Cohort A: sequential, cohort B parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT04199585
- Sponsor's protocol ID
- 18193A
- Status last verified
- May 2020
- First submitted
- 12 Dec 2019
- Last updated
- 12 May 2020
- 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 12 May 2020. 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 AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men
- ClinicalTrials.gov ID
- NCT04199585
- Acronym / sponsor ID
- 18193A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new safety data from another study
- Enrolment
- 18 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 16 Dec 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.
The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug
Detailed description
The study is divided in two parts, Part A and Part B:
Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men.
Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3)
Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Cohort A: sequential, cohort B parallel
| Arm | Type | Receives |
|---|---|---|
| Cohort A: single-ascending oral dose | Experimental | Drug: Lu AF95245, Drug: PlaceboCohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential |
| Cohort B: (fasting/fed conditions) | Experimental | Drug: Lu AF95245, Drug: Lu AF95245 14C radiolabelled spiked dosageGroups B1, B2, and B3, with 4 subjects in each group and the groups will be running in parallel. B1: fed-fasting-fasting condition (spiked dosage) B2: fasting-fed-fasting condition (spiked dosage) B3: fasting-fasting-fed condition |
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) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.
Key exclusion criteria (2 listed)
- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.
- Other in- 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 AF95245solution, single dose, orally | Drug | Cohort A: single-ascending oral dose, Cohort B: (fasting/fed conditions) |
| Lu AF95245 14C radiolabelled spiked dosagesolution, single dose, orally | Drug | Cohort B: (fasting/fed conditions) |
| Placebosolution, single dose, orally | Drug | Cohort A: single-ascending oral dose |
Primary outcome
Number of participants with treatment-emergent adverse events
Time frame: From baseline to Day 14
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
AUC(0-inf) Lu AF95245
Time frame: From 0 to 96 hours
Area under the plasma concentration time curve from zero to infinity
Cmax Lu AF95245
Time frame: From 0 to 96 hours
Maximum observed plasma concentration
CL/F Lu AF95245
Time frame: From 0 to 96 hours
Oral clearance for Lu AF95245 in plasma
Total recovery of the administered dose (% of dose in urine and faeces)
Time frame: From 0 to Day 14
Excretion of labelled Lu AF95245 in urine and faeces
Results and safety
The study was stopped early (reason given: new safety data from another study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- 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 AF95245 and Lu AF95245 14C radiolabelled spiked dosage 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 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: stopped early, as of the sponsor's last update on 12 May 2020. 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 was stopped early (reason given: new safety data from another study). Results are not available in the source record.
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 baseline to Day 14). The study lists 5 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 12 May 2020.