HealthyPhase 1NCT01975779
Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing Cohort B1: Lu AE58054 in people with Healthy, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cohort B1: Lu AE58054
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Oct 2013
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included).
Who cannot join
- The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomised, Double-blind, Placebocontrolled, Single- and Multiple-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.
Read the detailed description
The study will be conducted in two parts.
Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.
Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.
- Conditions
- Healthy
- Being tested
- Cohort A1: Lu AE58054 or placebo, Cohort A2: Lu AE58054 or placebo, Cohort B1: Lu AE58054
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort A1: Lu AE58054 or placeboDrug
One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.
Cohort A2: Lu AE58054 or placeboDrug
One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.
Cohort B1: Lu AE58054Drug
Two single oral doses 60 mg with >=7 days washout.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1: Lu AE58054 or placebo | Experimental | Not described Receives: Drug: Cohort A1: Lu AE58054 or placebo |
| Cohort A2: Lu AE58054 or placebo | Experimental | Not described Receives: Drug: Cohort A2: Lu AE58054 or placebo |
| Cohort B1: Lu AE58054 | Experimental | Not described Receives: Drug: Cohort B1: Lu AE58054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and frequency of adverse events
Standard clinical safety assessments
Measured: Up to Day 13
Number of subjects with adverse events
Adverse event monitoring
Measured: Up to Day 13
Secondary outcomes (6)
Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)
Measured: Day 9
Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)
Measured: Day 1
Maximum observed concentration (Cmax) and time of observation (tmax)
Measured: Day 1 and Day 9
Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)
Measured: Day 1 and Day 9
Accumulation index following multiple dosing of Lu AE58054 (AI)
Measured: Day 9
Risk of Suicidality
Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 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
- NCT01975779
- Sponsor's protocol ID
- 14917A
- Other IDs
- 2012-005648-10
- Status last verified
- Oct 2013
- First submitted
- 29 Oct 2013
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Placebocontrolled, Single- and Multiple-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT01975779
- Acronym / sponsor ID
- 14917A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 5 Nov 2013 (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 evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.
Detailed description
The study will be conducted in two parts.
Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.
Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A1: Lu AE58054 or placebo | Experimental | Drug: Cohort A1: Lu AE58054 or placebo |
| Cohort A2: Lu AE58054 or placebo | Experimental | Drug: Cohort A2: Lu AE58054 or placebo |
| Cohort B1: Lu AE58054 | Experimental | Drug: Cohort B1: Lu AE58054 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included).
Key exclusion criteria (2 listed)
- The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
- 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 |
|---|---|---|
| Cohort A1: Lu AE58054 or placeboOne single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo. | Drug | Cohort A1: Lu AE58054 or placebo |
| Cohort A2: Lu AE58054 or placeboOne single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo. | Drug | Cohort A2: Lu AE58054 or placebo |
| Cohort B1: Lu AE58054Two single oral doses 60 mg with >=7 days washout. | Drug | Cohort B1: Lu AE58054 |
Primary outcome
Number and frequency of adverse events
Time frame: Up to Day 13
Standard clinical safety assessments
Number of subjects with adverse events
Time frame: Up to Day 13
Adverse event monitoring
6 secondary outcomes
Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau)
Time frame: Day 9
Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf)
Time frame: Day 1
Maximum observed concentration (Cmax) and time of observation (tmax)
Time frame: Day 1 and Day 9
Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½)
Time frame: Day 1 and Day 9
Accumulation index following multiple dosing of Lu AE58054 (AI)
Time frame: Day 9
Risk of Suicidality
Time frame: Up to Day 13
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 5 Nov 2013.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Cohort B1: Lu AE58054 in people with Healthy, 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 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: finished, as of the sponsor's last update on 5 Nov 2013. 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?
Number and frequency of adverse events (time frame: Up to Day 13). 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 5 Nov 2013.