Healthy SubjectsPhase 1NCT03380455
Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects
A Phase 1 study testing Lucerastat and Cimetidine in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
Trial summary
A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. 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 Subjects
- What is being tested?
- Lucerastat and Cimetidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jan 2018to 29 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent in the local language prior to any study-mandated procedure.
- Body mass index from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Normal renal function confirmed by creatinine clearance ≥ 80 mL/min using Cockroft-Gault formula at Screening.
Who cannot join
- Known hypersensitivity to cimetidine, lucerastat, or drugs of the same class, or any of their excipients.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label Study to Investigate the Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Male Subjects
A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the concomitant administration of the two treatments will also be assessed.
- Conditions
- Healthy Subjects
- Being tested
- Lucerastat, Cimetidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucerastatDrug
Single oral dose of 500 mg lucerastat under fasted conditions
CimetidineDrug
Twice daily oral dose of 800 mg cimetidine under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment period A & B | Experimental | Treatment period A: Subjects receive a single oral dose of 500 mg lucerastat on Day 1 under fasted conditions.
Treatment period B: From Day 3 to Day 9, subjects receive a b.i.d. (every 12 h) oral dose of 800 mg cimetidine under fasted conditions (Treatment period B1; from Day 3 to Day 5). On Day 6, subjects receive a single oral dose of 500 mg lucerastat concomitantly with the morning dose of 800 mg cimetidine under fasted conditions (Treatment period B2; from Day 6 to Day 10). Receives: Drug: Lucerastat; Drug: Cimetidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Measured: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Tmax of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Measured: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
AUC(0-t) of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Measured: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
AUC(0-inf) of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Measured: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
AUC(0-48) of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Measured: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
T1/2 of lucerastat
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Measured: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Secondary outcomes (2)
Number of treatment-emergent AEs
Measured: From Day 1 to End-of-Study (for up to 13 days)
Number of treatment-emergent SAEs
Measured: From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start9 Jan 2018
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
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 Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Fixed sequence
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-Laure Boof, PhD, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380455
- Sponsor's protocol ID
- ID-069-105
- Status last verified
- Jun 2022
- First submitted
- 15 Dec 2017
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Boof ML, Halabi A, Ufer M, Dingemanse J. Impact of the organic cation transporter 2 inhibitor cimetidine on the single-dose pharmacokinetics of the glucosylceramide synthase inhibitor lucerastat in healthy subjects. Eur J Clin Pharmacol. 2020 Mar;76(3):431-437. doi: 10.1007/s00228-019-02808-9. Epub 2019 Dec 13.
PubMed 31836927
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label Study to Investigate the Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03380455
- Acronym / sponsor ID
- ID-069-105
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 21 Dec 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.
A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount and time of presence in the blood) of lucerastat. Safety of the concomitant administration of the two treatments will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed sequence
| Arm | Type | Receives |
|---|---|---|
| Treatment period A & B | Experimental | Drug: Lucerastat, Drug: CimetidineTreatment period A: Subjects receive a single oral dose of 500 mg lucerastat on Day 1 under fasted conditions. Treatment period B: From Day 3 to Day 9, subjects receive a b.i.d. (every 12 h) oral dose of 800 mg cimetidine under fasted conditions (Treatment period B1; from Day 3 to Day 5). On Day 6, subjects receive a single oral dose of 500 mg lucerastat concomitantly with the morning dose of 800 mg cimetidine under fasted conditions (Treatment period B2; from Day 6 to Day 10). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed informed consent in the local language prior to any study-mandated procedure.
- Body mass index from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Normal renal function confirmed by creatinine clearance ≥ 80 mL/min using Cockroft-Gault formula at Screening.
Key exclusion criteria (3 listed)
- Known hypersensitivity to cimetidine, lucerastat, or drugs of the same class, or any of their excipients.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- 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 |
|---|---|---|
| LucerastatSingle oral dose of 500 mg lucerastat under fasted conditions | Drug | Treatment period A & B |
| CimetidineTwice daily oral dose of 800 mg cimetidine under fasted conditions | Drug | Treatment period A & B |
Primary outcome
Cmax of lucerastat
Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
Tmax of lucerastat
Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
AUC(0-t) of lucerastat
Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
AUC(0-inf) of lucerastat
Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
AUC(0-48) of lucerastat
Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
T1/2 of lucerastat
Time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days
Plasma PK parameter of lucerastat after single-dose oral administration of lucerastat alone and in combination with cimetidine
2 secondary outcomes
Number of treatment-emergent AEs
Time frame: From Day 1 to End-of-Study (for up to 13 days)
Number of treatment-emergent SAEs
Time frame: From Screening to safety follow-up, i.e., 32 days after End-of-Study (for up to 63 days)
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 2 Jun 2022.
- Derived from this study: PubMed 31836927Boof ML, Halabi A, Ufer M, Dingemanse J. Impact of the organic cation transporter 2 inhibitor cimetidine on the single-dose pharmacokinetics of the glucosylceramide synthase inhibitor lucerastat in healthy subjects. Eur J Clin Pharmacol. 2020 Mar;76(3):431-437. doi: 10.1007/s00228-019-02808-9. Epub 2019 Dec 13.
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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.
Marie-Laure Boof, PhD 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 and Cimetidine in people with Healthy Subjects, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
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 3 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 2 Jun 2022. 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 Germany. 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?
Cmax of lucerastat (time frame: Up to 48 h after lucerastat administration on Day 1 (i.e., up to Day 3) and from pre-dose up to 96 h after lucerastat administration on Day 6 (i.e., up to Day 10); in total for up to 7 days). 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?
On the ClinicalTrials.gov record for NCT03380455, 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 2 Jun 2022.