Healthy Adult SubjectsPhase 1NCT05002231
Relative Bioavailability and Food Effect Study of Losmapimod 15 mg Tablets
A Phase 1 study testing Losmapimod 15 mg oral tablet, Losmapimod two 7.5 mg oral tablets and Losmapimod one 15 mg oral tablet in people with Healthy Adult Subjects, run by Fulcrum Therapeutics at 1 site in United States.
Trial summary
This is a study to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Losmapimod 15 mg oral tablet, Losmapimod two 7.5 mg oral tablets and Losmapimod one 15 mg oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 22 Oct 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects, 18 to 65 years of age, inclusive, at screening.
- Body mass index 18 to 30 kg/m2, inclusive, at screening with a minimum weight of 50 kg.
- Good general health, based upon the opinion of the investigator as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
- Willingness of men and women of reproductive potential must agree to use 2 effective and acceptable methods of contraception throughout study participation until 90 days after last dose of study drug. Female subjects must have a negative pregnancy test at screening and before the first dose of study drug.
- Willing and able to comply with all protocol requirements.
- The subject is able to provide written informed consent.
Who cannot join
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; clinically significant history of mental disease; and history of cancer, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the last 5 years).
- History of febrile illness within 5 days before the first dose of study drug.
- Current clinically significant liver or kidney dysfunction.
- Acute or chronic history of liver disease or current alanine aminotransferase elevation >1.5 × upper limit of normal (ULN) and/or total bilirubin >1.5 × ULN at screening.
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal tract surgery, except appendectomy).
Show all 25Show fewer
- Standard 12 lead ECG demonstrating QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 msec for male subjects and QTcF >470 msec for female subjects at screening. If QTcF exceeds 450 msec for males or 470 msec for females, the ECG will be repeated 2 more times, and the average of the 3 QTcF values will be used to determine the subject's eligibility.
- History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) or history or evidence of abnormal ECGs that, in the opinion of the investigator or medical monitor, would preclude the subject's participation in the study.
- Blood or blood product (e.g., plasma/serum) donation (of approximately 1 pint [500 mL] or more) or has any significant loss of blood within 3 months (males) or 4 months (females) prior to screening or intention to donate blood or blood products during the study as determined by the investigator.
- History of abuse of addictive substances such as drug abuse, or regular user of sedatives, hypnotics, tranquilizers, or any other addictive agent within 6 months prior to screening.
- History of regular alcohol consumption within 6 months prior to screening defined as an average weekly intake of greater than 21 units. One unit is equivalent to approximately half pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits.
- History of demonstrating an excess in xanthine consumption (more than 8 cups of coffee or equivalent per day).
- Received study drug in another investigational study within 30 days of dosing.
- Received the coronavirus disease 2019 (COVID-19) vaccine within 14 days before Day 1, or subjects who plan to receive a COVID-19 vaccine at any time during the study, including during the follow up period or has tested positive for COVID 19 within 3 months prior to screening.
- Use of any medication (prescription or over-the-counter) within 14 days of study drug administration, or use of herbal supplements, dietary supplements, or multivitamins within 7 days of study drug administration or less than five half-lives (whichever is longer), with the exception of contraceptives, hormonal replacement therapies, and acetaminophen (up to 3 grams per day). Other exceptions will only be made if the rationale is clearly documented by the investigator.
- History of sensitivity to the study drug, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicated their participation.
- Female subjects who are lactating or pregnant as determined by positive serum human chorionic gonadotropin test at screening or on Day -1.
- Subject is mentally or legally incapacitated.
- Abnormal laboratory results indicative of any significant medical disease that, in the opinion of the investigator, would preclude the subject's participation in the study at screening or prior to first dose of study drug.
- Subject, or close relative of the subject, is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that study site.
- Subject smokes cigarettes (or equivalent including vaping) and/or has used nicotine based products within 14 days prior to screening.
- Positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or on Day -1.
- Consumption of grapefruit or grapefruit juice, Seville orange or Seville orange containing products (e.g., marmalade), or alcohol-, caffeine-, or xanthine containing products within 48 hours before the first dose of study drug.
- Plans for hospitalization, surgery, or other major procedures during the study duration between the screening visit and Day -1.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 3-Period, Randomized, Single-Dose, Crossover Study to Assess the Relative Bioavailability and the Effect of Food on the Pharmacokinetics of a New 15 mg Tablet of Losmapimod Versus the Current 7.5 mg Tablet
This is a study to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod
Read the detailed description
This study is a Phase 1, open-label, 3-period, 6-sequence, randomized, single-dose, crossover study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions in 18 healthy subjects.
The study will consist of a screening period, 3 treatment periods with a single dose of study drug per treatment period, a 48-hour washout period between dosing, and an end of study visit. Subjects will be randomly assigned to receive 1 of 6 treatment sequences (3 subjects per treatment sequence) prior to dosing on Day 1 of Period 1.
The primary endpoint of the study is to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod. Secondary endpoints include assessing the safety and tolerability and evaluating target engagement in the blood of a new 15 mg tablet formulation of losmapimod in healthy subjects.
- Conditions
- Healthy Adult Subjects
- Being tested
- Losmapimod 15 mg oral tablet, Losmapimod two 7.5 mg oral tablets, Losmapimod one 15 mg oral tablet
- Keywords
- Healthy Adult Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losmapimod 15 mg oral tabletDrug
Subjects will receive one losmapimod 15 mg tablet by mouth under fasted conditions.
Losmapimod two 7.5 mg oral tabletsDrug
Subjects will receive two losmapimod 7.5 mg tablets by mouth under fasted conditions.
Losmapimod one 15 mg oral tabletDrug
Subjects will receive one losmapimod 15 mg tablet by mouth under fed conditions.
| Study group | Role | What they receive |
|---|---|---|
| Losmapimod 15 mg oral tablet in healthy subjects (Treatment Regimen A) | Experimental | Subjects will be randomized to 1 of 6 treatment sequences to receive one 15 mg tablet of losmapimod administered orally under fasted conditions. Subjects will fast overnight (nothing to eat or drink except water) for at least 10 hours before each study drug administration. Subjects will remain fasted for 4 hours after dosing with study drug. Washout period of 48 hours between dosing. Receives: Drug: Losmapimod 15 mg oral tablet |
| Losmapimod two 7.5 mg oral tablets in healthy subjects (Treatment Regimen B) | Experimental | Subjects will be randomized to 1 of 6 treatment sequences to receive two 7.5 mg tablets of losmapimod administered orally under fasted conditions. Subjects will fast overnight (nothing to eat or drink except water) for at least 10 hours before each study drug administration. Subjects will remain fasted for 4 hours after dosing with study drug. Washout period of 48 hours between dosing. Receives: Drug: Losmapimod two 7.5 mg oral tablets |
| Losmapimod one 15 mg oral tablet in healthy subjects (Treatment Regimen C) | Experimental | Subjects will be randomized to 1 of 6 treatment sequences to receive one 15 mg tablet of losmapimod administered orally under fed conditions. Subjects will fast overnight (nothing to eat or drink except water) for at least 10 hours before breakfast and will receive a high-fat breakfast approximately 30 minutes before dose administration. Subjects must consume the meal within 25 minutes or less. Washout period of 48 hours between dosing. Receives: Drug: Losmapimod one 15 mg oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentrations of Losmapimod
To assess the bioavailability of losmapimod (1 x 15 mg tablet) (test) versus losmapimod tablets (2 x 7.5 mg tablets) (reference), blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Measured: Treatment Regimen A: Days 1 and 2
Plasma Concentrations of Losmapimod
To assess the bioavailability of losmapimod (1 x 15 mg tablet) (test) versus losmapimod tablets (2 x 7.5 mg tablets) (reference), blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Measured: Treatment Regimen B: Days 1 and 2
Food Effect of Losmapimod
To assess the effect of food on the pharmacokinetics of losmapimod test versus reference, blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Measured: Treatment Regimen A: Days 1 and 2
Food Effect of Losmapimod
To assess the effect of food on the pharmacokinetics of losmapimod, blood samples will be collected after a high fat meal to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Measured: Treatment Regimen Part C: Days 1 and 2
Secondary outcomes (4)
Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of losmapimod 15 mg in healthy adult subjects based on the frequency of adverse events (AEs), frequency of serious adverse events (SAEs), and clinically significant laboratory test results, electrocardiograms (ECGs), vital signs and physical examination findings.
Measured: Up to approximately 4 weeks of monitoring
Target Engagement in Blood
Change from baseline in the ratio of phosphor-HSP27/total-HSP27 in sorbitol-stimulated whole blood lysate will be evaluated by enzyme linked immunosorbent assay (ELISA).
Measured: Treatment Regimen A: Day 1
Target Engagement in Blood
Change from baseline in the ratio of phosphor-HSP27/total-HSP27 in sorbitol-stimulated whole blood lysate will be evaluated by enzyme linked immunosorbent assay (ELISA).
Measured: Treatment Regimen B: Day 1
Target Engagement in Blood
Change from baseline in the ratio of phosphor-HSP27/total-HSP27 in sorbitol-stimulated whole blood lysate will be evaluated by enzyme linked immunosorbent assay (ELISA).
Measured: Treatment Regimen C: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start19 Aug 2021
- Primary completion5 Oct 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, 3-period, 6-sequence, randomized, single-dose, crossover study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fulcrum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Mellion, MD, Study director, Fulcrum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002231
- Sponsor's protocol ID
- 1821-CLP-101
- Status last verified
- Nov 2021
- First submitted
- 4 Aug 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.
PubMed 23215699Mellion ML, Ronco L, Berends CL, Pagan L, Brooks S, van Esdonk MJ, van Brummelen EMJ, Odueyungbo A, Thompson LA, Hage M, Badrising UA, Raines S, Tracewell WG, van Engelen B, Cadavid D, Groeneveld GJ. Phase 1 clinical trial of losmapimod in facioscapulohumeral dystrophy: Safety, tolerability, pharmacokinetics, and target engagement. Br J Clin Pharmacol. 2021 Dec;87(12):4658-4669. doi: 10.1111/bcp.14884. Epub 2021 May 14.
PubMed 33931884
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 3-Period, Randomized, Single-Dose, Crossover Study to Assess the Relative Bioavailability and the Effect of Food on the Pharmacokinetics of a New 15 mg Tablet of Losmapimod Versus the Current 7.5 mg Tablet
- ClinicalTrials.gov ID
- NCT05002231
- Acronym / sponsor ID
- 1821-CLP-101
- Conditions
- Healthy Adult Subjects
- Keywords
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fulcrum TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 12 Aug 2021 (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 is a study to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod
Detailed description
This study is a Phase 1, open-label, 3-period, 6-sequence, randomized, single-dose, crossover study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions in 18 healthy subjects.
The study will consist of a screening period, 3 treatment periods with a single dose of study drug per treatment period, a 48-hour washout period between dosing, and an end of study visit. Subjects will be randomly assigned to receive 1 of 6 treatment sequences (3 subjects per treatment sequence) prior to dosing on Day 1 of Period 1.
The primary endpoint of the study is to assess the relative bioavailability and the effect of food on the pharmacokinetics of a new 15 mg tablet formulation of losmapimod. Secondary endpoints include assessing the safety and tolerability and evaluating target engagement in the blood of a new 15 mg tablet formulation of losmapimod in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Open-label, 3-period, 6-sequence, randomized, single-dose, crossover study designed to assess the relative bioavailability of a 15 mg tablet of losmapimod versus two 7.5 mg tablets of losmapimod under fasted conditions and to assess the effect of food on the pharmacokinetics of a 15 mg tablet of losmapimod under fasted and fed conditions
| Arm | Type | Receives |
|---|---|---|
| Losmapimod 15 mg oral tablet in healthy subjects (Treatment Regimen A) | Experimental | Drug: Losmapimod 15 mg oral tabletSubjects will be randomized to 1 of 6 treatment sequences to receive one 15 mg tablet of losmapimod administered orally under fasted conditions. Subjects will fast overnight (nothing to eat or drink except water) for at least 10 hours before each study drug administration. Subjects will remain fasted for 4 hours after dosing with study drug. Washout period of 48 hours between dosing. |
| Losmapimod two 7.5 mg oral tablets in healthy subjects (Treatment Regimen B) | Experimental | Drug: Losmapimod two 7.5 mg oral tabletsSubjects will be randomized to 1 of 6 treatment sequences to receive two 7.5 mg tablets of losmapimod administered orally under fasted conditions. Subjects will fast overnight (nothing to eat or drink except water) for at least 10 hours before each study drug administration. Subjects will remain fasted for 4 hours after dosing with study drug. Washout period of 48 hours between dosing. |
| Losmapimod one 15 mg oral tablet in healthy subjects (Treatment Regimen C) | Experimental | Drug: Losmapimod one 15 mg oral tabletSubjects will be randomized to 1 of 6 treatment sequences to receive one 15 mg tablet of losmapimod administered orally under fed conditions. Subjects will fast overnight (nothing to eat or drink except water) for at least 10 hours before breakfast and will receive a high-fat breakfast approximately 30 minutes before dose administration. Subjects must consume the meal within 25 minutes or less. Washout period of 48 hours between dosing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or female subjects, 18 to 65 years of age, inclusive, at screening.
- Body mass index 18 to 30 kg/m2, inclusive, at screening with a minimum weight of 50 kg.
- Good general health, based upon the opinion of the investigator as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at screening.
- Willingness of men and women of reproductive potential must agree to use 2 effective and acceptable methods of contraception throughout study participation until 90 days after last dose of study drug. Female subjects must have a negative pregnancy test at screening and before the first dose of study drug.
- Willing and able to comply with all protocol requirements.
Key exclusion criteria (25 listed)
- History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; clinically significant history of mental disease; and history of cancer, except for squamous cell skin cancer, basal cell skin cancer, and Stage 0 cervical carcinoma in situ (all 3 with no recurrence for the last 5 years).
- History of febrile illness within 5 days before the first dose of study drug.
- Current clinically significant liver or kidney dysfunction.
- Acute or chronic history of liver disease or current alanine aminotransferase elevation >1.5 × upper limit of normal (ULN) and/or total bilirubin >1.5 × ULN at screening.
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
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 |
|---|---|---|
| Losmapimod 15 mg oral tabletSubjects will receive one losmapimod 15 mg tablet by mouth under fasted conditions. | Drug | Losmapimod 15 mg oral tablet in healthy subjects (Treatment Regimen A) |
| Losmapimod two 7.5 mg oral tabletsSubjects will receive two losmapimod 7.5 mg tablets by mouth under fasted conditions. | Drug | Losmapimod two 7.5 mg oral tablets in healthy subjects (Treatment Regimen B) |
| Losmapimod one 15 mg oral tabletSubjects will receive one losmapimod 15 mg tablet by mouth under fed conditions. | Drug | Losmapimod one 15 mg oral tablet in healthy subjects (Treatment Regimen C) |
Primary outcome
Plasma Concentrations of Losmapimod
Time frame: Treatment Regimen A: Days 1 and 2
To assess the bioavailability of losmapimod (1 x 15 mg tablet) (test) versus losmapimod tablets (2 x 7.5 mg tablets) (reference), blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Plasma Concentrations of Losmapimod
Time frame: Treatment Regimen B: Days 1 and 2
To assess the bioavailability of losmapimod (1 x 15 mg tablet) (test) versus losmapimod tablets (2 x 7.5 mg tablets) (reference), blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Food Effect of Losmapimod
Time frame: Treatment Regimen A: Days 1 and 2
To assess the effect of food on the pharmacokinetics of losmapimod test versus reference, blood samples will be collected under fasted conditions to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
Food Effect of Losmapimod
Time frame: Treatment Regimen Part C: Days 1 and 2
To assess the effect of food on the pharmacokinetics of losmapimod, blood samples will be collected after a high fat meal to measure the plasma concentration of losmapimod at specified timepoints by liquid chromatography with tandem mass spectrometry.
4 secondary outcomes
Treatment-Emergent Adverse Events
Time frame: Up to approximately 4 weeks of monitoring
Target Engagement in Blood
Time frame: Treatment Regimen A: Day 1
Target Engagement in Blood
Time frame: Treatment Regimen B: Day 1
Target Engagement in Blood
Time frame: Treatment Regimen C: Day 1
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 12 Nov 2021.
- Background: PubMed 23215699Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.
- Background: PubMed 33931884Mellion ML, Ronco L, Berends CL, Pagan L, Brooks S, van Esdonk MJ, van Brummelen EMJ, Odueyungbo A, Thompson LA, Hage M, Badrising UA, Raines S, Tracewell WG, van Engelen B, Cadavid D, Groeneveld GJ. Phase 1 clinical trial of losmapimod in facioscapulohumeral dystrophy: Safety, tolerability, pharmacokinetics, and target engagement. Br J Clin Pharmacol. 2021 Dec;87(12):4658-4669. doi: 10.1111/bcp.14884. Epub 2021 May 14.
- Individual participant dataSharing planned: No
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Healthy Subjects
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.
Michelle Mellion, MD study director
Fulcrum Therapeutics
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 Losmapimod 15 mg oral tablet, Losmapimod two 7.5 mg oral tablets and Losmapimod one 15 mg oral tablet in people with Healthy Adult Subjects, run by Fulcrum Therapeutics at 1 site in United States.
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 6 inclusion and 25 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 12 Nov 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 United States. 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?
Plasma Concentrations of Losmapimod (time frame: Treatment Regimen A: Days 1 and 2). The study lists 4 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 NCT05002231, which also lists 2 linked publications.
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 Nov 2021.