A Phase 1 interventional study of [14C]-resminostat in Cutaneous T Cell Lymphoma, Mycosis Fungoides and Sezary Syndrome, sponsored by 4SC AG. Completed at 1 site in United Kingdom. Open to male participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by 4SC AG · Phase 1, Interventional, and Treatment
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Among 25 studies in Lymphoma, T-Cell, Cutaneous with a site in United Kingdom — 1 open to participants now, 3 under way, none of them phase 3. Lymphoma, T-Cell, Cutaneous · United Kingdom.
Among the 25 studies in Lymphoma, T-Cell, Cutaneous with a site in United Kingdom, this one is the 21st largest by enrollment of the 22 interventional ones that give a count, is one of 3 that started in 2021, is one of 3 in phase 1, and was the 24th registered.
554 studies on the registry are indexed under Lymphoma, T-Cell, Cutaneous; 63 are open to participants now.
Browse Lymphoma, T-Cell, Cutaneous studies →1 of the 25 studies in Lymphoma, T-Cell, Cutaneous with a site in United Kingdom is open now. Recruiting first, the newest first:
European Organisation for Research and Treatment of Cancer - EORTC · Sites in United Kingdom, Denmark, France and 4 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 44 Lymphoma, T-Cell, Cutaneous studies recruiting now, 33 (75%) set no upper age limit and 6 (14%) stop at 75 or younger; 5 take children under 18; 4 take healthy volunteers.
This study: 35 Years to 55 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 3 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5 is below the median of 35 across 405 interventional studies indexed under Lymphoma, T-Cell, Cutaneous.
Median enrollment 48 across the 22 interventional studies, 14,000 across the 1 observational. Of the 18 that completed or were terminated, 4 (22%) have results posted.
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15 of 25 have an industry lead sponsor. The 10 most frequent:
4SC AG is the lead sponsor of 13 studies on the registry; none are open to participants now.
4SC AG has 2 studies filed under Lymphoma, T-Cell, Cutaneous — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 25 studies in Lymphoma, T-Cell, Cutaneous with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single dose of 400 mg \[14C\]-resminostat
Drug: [14C]-resminostat
1 single dose of 400 mg \[14C\]-resminostat
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Safety and Tolerability
AE reporting including relatedness and severity
Time frame: from study drug intake until 28 days after study drug administration
Heart rhythm
ECG analysis by 12-lead ECG
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Ventricular rate
ECG analysis by 12-lead ECG
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
PR-interval (synonymous: PQ interval)
ECG analysis by 12-lead ECG
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QRS complex
ECG analysis by 12-lead ECG
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QT interval
ECG analysis by 12-lead ECG
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
QTcF interval
ECG analysis by 12-lead ECG
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From day -1 until maximum 15 days after single dose of [14C]-resminostat
Ran from Oct 2021 to primary completion in Jan 2022, 3 months.
Of 45 phase 1 interventional studies under Lymphoma, T-Cell, Cutaneous, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 80. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Resminostat
4SC AG