HealthyPhase 1NCT03832452
A Study in Healthy Subjects to Investigate Whether Administration of Lucerastat Can Affect Normal Heart Function
A Phase 1 study testing Lucerastat (Treatment A), Moxifloxacin and Lucerastat (Treatment B) in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Netherlands.
Trial summary
Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lucerastat (Treatment A), Moxifloxacin and Lucerastat (Treatment B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Feb 2019to 22 Apr 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
- Part A only:
- Healthy male subjects aged between 18 and 55 years.
- Part B only:
- Healthy male and female subjects aged between 18 and 55 years.
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of the first period. They must consistently and correctly use a highly effective method of contraception, or be sexually inactive, or have a vasectomized partner.
- Women of nonchildbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).
Show all 10Show fewer
- Part A and B:
- Signed informed consent prior to any study-mandated procedure.
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening. Body weight at least 50.0 kg at Screening and prior to first study treatment administration.
- Healthy on the basis of medical history, physical examination, cardiovascular assessments and clinical laboratory tests.
Who cannot join
- Part B only:
- Known hypersensitivity to moxifloxacin or any of its excipients.
- Pregnant or lactating women.
- Women planning to become pregnant.
- Part A and B:
- Previous exposure to lucerastat.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- History or presence of rhythm disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-center, Randomized, Double-blind, Placebo-controlled, Two-part Phase 1 Study to Assess the Effect of Single Therapeutic and Supra-therapeutic Doses of Lucerastat on the QT/QTc Interval Duration in Healthy Subjects
Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study)
- Conditions
- Healthy
- Being tested
- Lucerastat (Treatment A), Placebo, Moxifloxacin, Lucerastat (Treatment B), Lucerastat (Treatment C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucerastat (Treatment A)Drug
2000 and 4000 mg; hard capsules for oral administration
PlaceboOther
hard capsules for oral administration
MoxifloxacinDrug
400 mg; film-coated tablets for oral administration
Lucerastat (Treatment B)Drug
1000 mg; hard capsules for oral administration
Lucerastat (Treatment C)Drug
4000 mg; hard capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part A: Treatment 1 | Experimental | A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3 Receives: Drug: Lucerastat (Treatment A) |
| Part A: Treatment 2 | Placebo comparator | A single oral dose of placebo on Day 1 and 3 Receives: Other: Placebo |
| Part B: Treatment A | Active comparator | A single oral dose of 400 mg moxifloxacin Receives: Drug: Moxifloxacin |
| Part B: Treatment B | Experimental | A single oral dose of 1000 mg lucerastat Receives: Drug: Lucerastat (Treatment B) |
| Part B: Treatment C | Experimental | A single oral dose of 4000 mg lucerastat Receives: Drug: Lucerastat (Treatment C) |
| Part B: Treatment D | Placebo comparator | A single oral dose of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
QTcF = QT interval corrected with Fridericia's formula; ΔΔQTcF = Placebo-corrected change-from-baseline QTcF
Measured: From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start14 Feb 2019
- Primary completion22 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study (Part A: parallel, 2 treatments; Part B: crossover, 4 treatments)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832452
- Sponsor's protocol ID
- ID-069-106
- Other IDs
- 2018-004546-42, 2018
- Status last verified
- Oct 2019
- First submitted
- 5 Feb 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller MS, Sidharta PN, Voors-Pette C, Darpo B, Xue H, Dingemanse J. The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects. Orphanet J Rare Dis. 2020 Oct 27;15(1):303. doi: 10.1186/s13023-020-01582-7.
PubMed 33109218
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Randomized, Double-blind, Placebo-controlled, Two-part Phase 1 Study to Assess the Effect of Single Therapeutic and Supra-therapeutic Doses of Lucerastat on the QT/QTc Interval Duration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03832452
- Acronym / sponsor ID
- ID-069-106
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 22 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 6 Feb 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.
Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Prospective, single-center, randomized, double-blind, placebo-controlled, two-part Phase 1 study (Part A: parallel, 2 treatments; Part B: crossover, 4 treatments)
| Arm | Type | Receives |
|---|---|---|
| Part A: Treatment 1 | Experimental | Drug: Lucerastat (Treatment A)A single oral dose of 2000 mg lucerastat on Day 1 and of 4000 mg lucerastat on Day 3 |
| Part A: Treatment 2 | Placebo comparator | Other: PlaceboA single oral dose of placebo on Day 1 and 3 |
| Part B: Treatment A | Active comparator | Drug: MoxifloxacinA single oral dose of 400 mg moxifloxacin |
| Part B: Treatment B | Experimental | Drug: Lucerastat (Treatment B)A single oral dose of 1000 mg lucerastat |
| Part B: Treatment C | Experimental | Drug: Lucerastat (Treatment C)A single oral dose of 4000 mg lucerastat |
| Part B: Treatment D | Placebo comparator | Other: PlaceboA single oral dose of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male subjects aged between 18 and 55 years.
- Healthy male and female subjects aged between 18 and 55 years.
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose of the first period. They must consistently and correctly use a highly effective method of contraception, or be sexually inactive, or have a vasectomized partner.
- Women of nonchildbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).
- Signed informed consent prior to any study-mandated procedure.
Key exclusion criteria (8 listed)
- Known hypersensitivity to moxifloxacin or any of its excipients.
- Pregnant or lactating women.
- Women planning to become pregnant.
- Previous exposure to lucerastat.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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 |
|---|---|---|
| Lucerastat (Treatment A)2000 and 4000 mg; hard capsules for oral administration | Drug | Part A: Treatment 1 |
| Placebohard capsules for oral administration | Other | Part A: Treatment 2, Part B: Treatment D |
| Moxifloxacin400 mg; film-coated tablets for oral administration | Drug | Part B: Treatment A |
| Lucerastat (Treatment B)1000 mg; hard capsules for oral administration | Drug | Part B: Treatment B |
| Lucerastat (Treatment C)4000 mg; hard capsules for oral administration | Drug | Part B: Treatment C |
Primary outcome
Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
Time frame: From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)
QTcF = QT interval corrected with Fridericia's formula; ΔΔQTcF = Placebo-corrected change-from-baseline QTcF
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 31 Oct 2019.
- Derived from this study: PubMed 33109218Mueller MS, Sidharta PN, Voors-Pette C, Darpo B, Xue H, Dingemanse J. The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects. Orphanet J Rare Dis. 2020 Oct 27;15(1):303. doi: 10.1186/s13023-020-01582-7.
- Individual participant dataSharing planned: No
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.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
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 Lucerastat (Treatment A), Moxifloxacin and Lucerastat (Treatment B) in people with Healthy, run by Idorsia Pharmaceuticals Ltd. 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 10 inclusion and 8 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 31 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 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. Some participants in this study may receive a placebo. 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?
Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF) (time frame: From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03832452, which also lists 1 linked publication.
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 31 Oct 2019.