Cutaneous T Cell LymphomaPhase 1NCT04955340
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat
A Phase 1 study testing [14C]-resminostat in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by 4SC AG at 1 site in United Kingdom.
Trial summary
Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets epigenetic changes observed in tumour cells and has the potential to provide significant benefit to patients with advanced malignancies by… Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cutaneous T Cell Lymphoma, Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- [14C]-resminostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2021to 19 Jan 2022
- 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 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age between 35 (inclusive) and 55 years of age (inclusive)
- Body mass index between 18.0 and 28.0 kg/m2, inclusive but at least 60 kg of body weight.
- Healthy, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert Meulengracht's syndrome based on total and direct bilirubin] is not acceptable) at screening and/or check-in as assessed by the investigator (or designee).
- Subjects must agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions
- History of a minimum of 1 bowel movement per day.
- Subjects must agree not to donate sperm from check-in until 90 days after discharge.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Any of the following abnormalities in laboratory test values and/or ECG at screening and/or check-in, confirmed by repeat: hemoglobin, white blood cell count, total platelets, and QTcF outside of normal range; alanine aminotransferase, aspartate aminotransferase, and creatinine values > upper limit of normal; and estimated glomerular filtration rate (calculated using Cockcroft-Gault formula) <60 mL/min.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Confirmed (eg, 2 consecutive measurements) systolic blood pressure >150 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >90 or <40 beats per minute.
- History of alcoholism or drug/chemical abuse within 2 years prior to screening.
Show all 23Show fewer
- Alcohol consumption of > 21 units per week. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives, whichever is longer prior to dosing.
- Administration of any vaccination (including vaccines currently being deployed in the UK for SARS-CoV-27) within the past 90 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, and excretion processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine test at screening or check-in.
- Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Subjects who have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical research Unit Ltd.
Leeds, LS2 9LH
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat Following a Single Oral Dose in Healthy Male Subjects
Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets epigenetic changes observed in tumour cells and has the potential to provide significant benefit to patients with advanced malignancies by inhibiting tumour progression and metastasis or even inducing tumour regression.
This will be a Phase 1, open-label, non-randomized, single dose study of the absorption, metabolism, excretion of [14C] resminostat following a single oral dose in healthy male participants.
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C] resminostat and to characterize and determine the metabolites present in plasma, urine, and, where possible, faeces in healthy male participants following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the International Conference on Harmonisation (ICH) M3, and the likelihood of effects of renal or hepatic impairment on the disposition of resminostat, and the likelihood for drug-drug interactions with resminostat. The results from this study may guide future study designs using special populations or evaluating the potential for drug-drug interactions.
- Being tested
- [14C]-resminostat
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-resminostatDrug
1 single dose of 400 mg [14C]-resminostat
| Study group | Role | What they receive |
|---|---|---|
| [14C]-resminostat | Experimental | single dose of 400 mg [14C]-resminostat Receives: Drug: [14C]-resminostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-tlast
AUC from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC0-∞
AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Cmax
maximum observed concentration derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
tmax
time to reach Cmax derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
tlag
time to the first quantifiable concentration in plasma derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
λz
terminal elimination rate constant derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
t1/2
apparent terminal elimination half-life derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
CL/F
apparent total clearance derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Vz/F
apparent volume of distribution derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC0-∞ Plasma resminostat/Total Radioactivity Ratio
AUC0-∞ of plasma resminostat relative to AUC0-∞ of plasma total radioactivity derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC0-∞ Blood/Plasma Ratio
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Aeu
amount excreted in urine derived from urine collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative Aeu
cumulative amount excreted in urine derived from urine collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
feu
percentage excreted in urine derived from urine collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative feu
cumulative percentage excreted in urine derived from urine collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Aef
amount excreted in feces derived from feces collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative Aef
cumulative amount excreted in feces derived from feces collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
fef
percentage excreted in feces derived from feces collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative fef.
cumulative percentage excreted in feces derived from feces collections at each sampling interval
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Secondary outcomes (12)
Safety and Tolerability
AE reporting including relatedness and severity
Measured: from study drug intake until 28 days after study drug administration
Heart rhythm
ECG analysis by 12-lead ECG
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Ventricular rate
ECG analysis by 12-lead ECG
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
PR-interval (synonymous: PQ interval)
ECG analysis by 12-lead ECG
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QRS complex
ECG analysis by 12-lead ECG
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QT interval
ECG analysis by 12-lead ECG
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QTcF interval
ECG analysis by 12-lead ECG
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Vital Signs (Body Temperature)
Body temperature will be measured after a 5 minute rest in supine position
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Vital Signs (Blood pressure)
Systolic and diastolic blood pressure will be measured after a 5 minute rest in supine position
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Physical Examination
A full physical examination covering at least head, eyes, ears, nose and throat, lungs, heart, neurological status, abdomen, extremities, skin, and lymph nodes
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
metabolic profiles of resminostat
identification and quantification of metabolites in serum and urin samples by HPLC
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
identification and quantification of resminostat metabolites
identification and quantification of metabolites in serum and urin samples by HPLC
Measured: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start12 Oct 2021
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T Cell LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4SC AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955340
- Sponsor's protocol ID
- 4SC-201-7-2020
- Other IDs
- 2021-000555-39, 8448213
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04955340
- Acronym / sponsor ID
- 4SC-201-7-2020
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- 4SC AGIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 8 Jul 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.
Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets epigenetic changes observed in tumour cells and has the potential to provide significant benefit to patients with advanced malignancies by inhibiting tumour progression and metastasis or even inducing tumour regression.
This will be a Phase 1, open-label, non-randomized, single dose study of the absorption, metabolism, excretion of [14C] resminostat following a single oral dose in healthy male participants.
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C] resminostat and to characterize and determine the metabolites present in plasma, urine, and, where possible, faeces in healthy male participants following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the International Conference on Harmonisation (ICH) M3, and the likelihood of effects of renal or hepatic impairment on the disposition of resminostat, and the likelihood for drug-drug interactions with resminostat. The results from this study may guide future study designs using special populations or evaluating the potential for drug-drug interactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-resminostat | Experimental | Drug: [14C]-resminostatsingle dose of 400 mg [14C]-resminostat |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male
- Age between 35 (inclusive) and 55 years of age (inclusive)
- Body mass index between 18.0 and 28.0 kg/m2, inclusive but at least 60 kg of body weight.
- Healthy, as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert Meulengracht's syndrome based on total and direct bilirubin] is not acceptable) at screening and/or check-in as assessed by the investigator (or designee).
- Subjects must agree to use contraception
Key exclusion criteria (23 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Any of the following abnormalities in laboratory test values and/or ECG at screening and/or check-in, confirmed by repeat: hemoglobin, white blood cell count, total platelets, and QTcF outside of normal range; alanine aminotransferase, aspartate aminotransferase, and creatinine values > upper limit of normal; and estimated glomerular filtration rate (calculated using Cockcroft-Gault formula) <60 mL/min.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Confirmed (eg, 2 consecutive measurements) systolic blood pressure >150 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >90 or <40 beats per minute.
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 |
|---|---|---|
| [14C]-resminostat1 single dose of 400 mg [14C]-resminostat | Drug | [14C]-resminostat |
Primary outcome
AUC0-tlast
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
AUC0-∞
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Cmax
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
maximum observed concentration derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
tmax
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
time to reach Cmax derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
tlag
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
time to the first quantifiable concentration in plasma derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
λz
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
terminal elimination rate constant derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
t1/2
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
apparent terminal elimination half-life derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
CL/F
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
apparent total clearance derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Vz/F
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
apparent volume of distribution derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
AUC0-∞ Plasma resminostat/Total Radioactivity Ratio
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC0-∞ of plasma resminostat relative to AUC0-∞ of plasma total radioactivity derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
AUC0-∞ Blood/Plasma Ratio
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity derived from the whole blood and plasma concentration-time profiles following oral administration of [14C]-resminostat
Aeu
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
amount excreted in urine derived from urine collections at each sampling interval
cumulative Aeu
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative amount excreted in urine derived from urine collections at each sampling interval
feu
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
percentage excreted in urine derived from urine collections at each sampling interval
cumulative feu
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative percentage excreted in urine derived from urine collections at each sampling interval
Aef
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
amount excreted in feces derived from feces collections at each sampling interval
cumulative Aef
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative amount excreted in feces derived from feces collections at each sampling interval
fef
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
percentage excreted in feces derived from feces collections at each sampling interval
cumulative fef.
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
cumulative percentage excreted in feces derived from feces collections at each sampling interval
12 secondary outcomes
Safety and Tolerability
Time frame: from study drug intake until 28 days after study drug administration
Heart rhythm
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Ventricular rate
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
PR-interval (synonymous: PQ interval)
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QRS complex
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QT interval
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QTcF interval
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Vital Signs (Body Temperature)
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Vital Signs (Blood pressure)
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Physical Examination
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
metabolic profiles of resminostat
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
identification and quantification of resminostat metabolites
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
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 18 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]-resminostat in people with Cutaneous T Cell Lymphoma and Mycosis Fungoides, run by 4SC AG 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 8 inclusion and 23 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 18 Feb 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 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?
AUC0-tlast (time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat). The study lists 19 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 18 Feb 2022.