HealthyEarly Phase 1NCT06797427
A Study to Assess the Pharmacokinetics of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers
A Early Phase 1 study testing DPH001 and Nexavar (Sorafenib) in people with Healthy, run by Disruptive Pharma at 1 site in Sweden.
Trial summary
The study aims to assess the pharmacokinetics and safety of DPH001, an amorphous formulation of sorafenib, compared to Nexavar® in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DPH001 and Nexavar (Sorafenib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 10 Feb 2025to 10 Mar 2025
- Phase
- Early 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
- Willing and able to give written informed consent for participation in the trial, including consenting to the planned restrictions during the trial.
- Healthy male or female participant aged 18 to 65 years, inclusive.
- Body mass index (BMI) ≥18.5 and ≤30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical/surgical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
- Female trial participants: Only female participants of non-childbearing potential will be considered eligible for participation. Female participants of non-childbearing potential are defined as:
- pre menopausal females who have undergone hysterectomy and/or bilateral salpingectomy and/or bilateral oophorectomy,
Show all 12Show fewer
- post menopausal females, defined as having undergone at least 12 months of amenorrhea. In questionable cases a blood sample with detection of follicle stimulating hormone (FSH) >25 IU/L will be confirmatory.
- Male trial participants: Male participants must be willing to use condoms during sexual intercourse to prevent pregnancy and/or the drug exposure of a partner from the first IMP administration at Visit 2 and until 3 months after the last IMP administration at Visit 12.
- In addition, any female partner of a male participant who is of childbearing potential must use contraceptive methods with a failure rate of <1%/year to prevent pregnancy from at least 2 weeks prior to the first administration of IMP to 3 months after the last administration of IMP.
- The following are considered highly effective methods of contraception:
- combined (oestrogen and progestogen-containing) or progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, transdermal, intravaginal, injectable, or implantable),
- intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or HIV antigen and antibodies.
- After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges:
Show all 28Show fewer
- systolic blood pressure: <90 or ≥140 mmHg, or
- diastolic blood pressure <50 or ≥90 mmHg, or
- pulse <40 or ≥90 bpm.
- A mean QTcF interval of ≥450 ms at screening or a family history of long QT syndrome, as judged by the Investigator.
- Abnormal ECG morphology at screening, including abnormality in PR and/or QRS intervals, as well as signs of bundle branch block (BBB), as judged by the Investigator.
- History of cardiac arrhythmias or palpitations, including ectopic heart beats and/or extra systoles (premature ventricular contractions), as judged by the Investigator.
- Hepatic dysfunction, defined as serum transaminase (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) levels above the upper limit of normal (ULN) at screening, if considered clinically significant by the Investigator.
- Any other clinically relevant abnormalities in clinical chemistry, haematology, and coagulation parameters from safety laboratory tests at screening, at the discretion of the Investigator.
- History of severe reaction, including allergy/hypersensitivity, to drugs with a similar chemical structure, class, or mechanism of action to sorafenib, and/or reaction to any drug that led to significant morbidity, as judged by the Investigator.
- History of or ongoing major depressive disorder (MDD) and/or any history of suicidal ideation (i.e., active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent), at the discretion of the Investigator.
- Regular use of any prescribed or non-prescribed medications, at the discretion of the Investigator, including antacids, analgesics, antibiotics, anticoagulants, non-steroidal anti-inflammatory drugs, herbal remedies, vitamins, and mineral, within 2 weeks prior to the first planned IMP administration at Visit 2, except the following:
- Prescribed and stable treatment with any hormone replacement therapy (HRT).
- Occasional intake of paracetamol (maximum 2000 mg/day for a maximum of 3 consecutive days and not exceeding 3000 mg/week).
- Nasal decongestants without cortisone, antihistamine, or anticholinergics for a maximum of 10 days.
- Planned treatment or treatment with another investigational drug within 3 months prior to Visit 2. Participants consented and screened but not dosed in previous phase I trials will not be excluded.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times/week before the screening visit will be allowed.
- Positive test result for drugs of abuse or alcohol at screening.
- History or manifestation at screening of drug abuse, alcohol abuse and/or excessive intake of alcohol, as judged by the Investigator.
- History of, or current use, of anabolic steroids, as judged by the Investigator.
- Excessive caffeine consumption defined by a daily intake of >5 cups (1 cup = approximately 240 mL) of caffeine-containing beverages, as judged by the Investigator.
- Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Trial Consultants (CTC), Dag Hammarskjölds väg 10B
Uppsala, 752 37
About this study
Official title: An Open-label, Prospective, Randomised, Cross-over Trial to Assess the Pharmacokinetics of an Amorphous Formulation of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers
The study aims to assess the pharmacokinetics and safety of DPH001, an amorphous formulation of sorafenib, compared to Nexavar® in healthy volunteers.
Read the detailed description
This is an open-label, prospective, randomized, cross-over, single-center trial designed to evaluate the bioavailability, safety, and tolerability of DPH001 compared to Nexavar® in healthy male participants and healthy female participants of non-childbearing potential. The objective of the study is to compare the pharmacokinetics (PK) of sorafenib after the administration of 100 mg DPH001 vs. after the administration of 200 mg Nexavar®. After being informed of the study and potential risks, all subjects given written informed consent will undergo a screening to determine eligibility for study entry. Participants will receive, in a randomized order, 1 dose of 100 mg DPH001, and 1 dose of 200 mg Nexavar®, all in a fasted state. IMP administrations will be separated by wash-out periods of at least 14 days.
- Conditions
- Healthy
- Being tested
- DPH001, Nexavar (Sorafenib)
- Keywords
- PK study, Sorafenib, Hepatocellular carcinoma, MMC, Amorphous formulation, Mesoporous magnesium carbonate, Absorption, Bioavailability, Drug delivery, Kinase inhibitors
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPH001Drug
100 mg
Nexavar (Sorafenib)Drug
200 mg
| Study group | Role | What they receive |
|---|---|---|
| Single dose of Nexavar sorafenib | Active comparator | 1 dose of 200 mg sorafenib as Nexavar®, film-coated tablets for oral administration, in a fasted state. IMP administrations (dosing) will be separated by wash-out periods of at least 14 days Receives: Drug: Nexavar (Sorafenib) |
| Singel dose of DPH001 | Experimental | 1 dose of 100 mg sorafenib as DPH001, HPMC capsuls for oral administration, in a fasted state. IMP administrations (dosing) will be separated by wash-out periods of at least 14 days Receives: Drug: DPH001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the AUC (0-6h) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Blood samples will be collected in order to calculate a PK-profile. Area under the plasma concentration vs. time curve (AUC) from time 0 to 6 hours (AUC0 6h).
Measured: From administration of study drug until 4 days
To compare the AUC (0-72 h) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Blood samples will be collected in order to calculate a PK-profile. Area under the plasma concentration vs. time curve (AUC) from time 0 to 72 hours (AUC 0-72h).
Measured: From administration of study drug until 4 days
To compare the AUC (inf) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Blood samples will be collected in order to calculate a PK-profile. Area under the plasma concentration vs. time curve (AUC) from time 0 extrapolated to infinity (AUCinf).
Measured: From administration of study drug until 4 days
To compare the Cmax of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Blood samples will be collected in order to calculate a PK-profile. Maximum observed plasma concentration (Cmax).
Measured: From administration of study drug until 4 days
To compare the Tmax of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Blood samples will be collected in order to calculate a PK-profile. Time to Cmax (Tmax).
Measured: From administration of study drug until 4 days
Secondary outcomes (34)
Number of subjects with treatment-related adverse events assessed by frequency.
Number of events. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by seriouness.
The seriousness of events. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by intensity.
The intensity of events. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by relationship to study treatment.
The relationship to study treatment. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the systolic blood pressure.
Measured in mmHg, supine position after 10 minutes rest. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the diastolic blood pressure.
Measured in mmHg, supine position after 10 minutes rest. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter QRS.
Measured in ms, supine position after 10 minutes rest using an ECG machine. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter QT.
Measured in ms, supine position after 10 minutes rest using an ECG machine. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR.
Measured in ms, supine position after 10 minutes rest using an ECG machine. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter QTcF.
Measured in ms, supine position after 10 minutes rest using an ECG machine. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter heart rate.
Measured in ms, supine position after 10 minutes rest using an ECG machine. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the clinical chemistry parameters.
Blood samples for analyzing hematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the hematology parameters.
Blood samples for analyzing hematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the coagulation parameters.
Blood samples for analyzing hematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the head.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the eyes.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the ears.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the nose.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the throat.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the skin.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the thyroid.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the neurological.
Physical examination. Descriptive individual data.
Measured: From administration of study drug end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the lungs.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the cardiovascular.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the abdomen (liver and spleen).
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the lymphnodes.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the extremities.
Physical examination. Descriptive individual data.
Measured: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by frequency.
Number of events. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Number of subjects with treatment-related adverse events assessed by seriouness.
The seriousness of events. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Number of subjects with treatment-related adverse events assessed by intensity.
The intensity of events. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Number of subjects with treatment-related adverse events assessed by relationship to study treatment.
The relationship to study treatment. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Number of subjects with a clinical significant change from baseline in the clinical chemistry parameters.
Blood samples for analyzing hematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Number of subjects with a clinical significant change from baseline in the hematology parameters.
Blood samples for analyzing hematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Number of subjects with a clinical significant change from baseline in the coagulation parameters.
Blood samples for analyzing hematology parameters will be collected through venepuncture or an indwelling venous catheter. Descriptive individual data.
Measured: From administration of study drug until 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start10 Feb 2025
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Disruptive Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Björn Schultze, MD, Principal investigator, Clinical Trial Consultants (CTC), Dag Hammarskjölds väg 10B, 752 37 Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797427
- Sponsor's protocol ID
- DPH001-01
- Other IDs
- 2024-514496-18
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Randomised, Cross-over Trial to Assess the Pharmacokinetics of an Amorphous Formulation of Sorafenib in Mesoporous Magnesium Carbonate (DPH001) Compared to Nexavar® (sorafenib) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06797427
- Acronym / sponsor ID
- DPH001-01
- Conditions
- Healthy
- Keywords
- PK study, Sorafenib, Hepatocellular carcinoma, MMC, Amorphous formulation, Mesoporous magnesium carbonate, Absorption, Bioavailability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Disruptive PharmaIndustry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 28 Jan 2025 (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.
The study aims to assess the pharmacokinetics and safety of DPH001, an amorphous formulation of sorafenib, compared to Nexavar® in healthy volunteers.
Detailed description
This is an open-label, prospective, randomized, cross-over, single-center trial designed to evaluate the bioavailability, safety, and tolerability of DPH001 compared to Nexavar® in healthy male participants and healthy female participants of non-childbearing potential. The objective of the study is to compare the pharmacokinetics (PK) of sorafenib after the administration of 100 mg DPH001 vs. after the administration of 200 mg Nexavar®. After being informed of the study and potential risks, all subjects given written informed consent will undergo a screening to determine eligibility for study entry. Participants will receive, in a randomized order, 1 dose of 100 mg DPH001, and 1 dose of 200 mg Nexavar®, all in a fasted state. IMP administrations will be separated by wash-out periods of at least 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of Nexavar sorafenib | Active comparator | Drug: Nexavar (Sorafenib)1 dose of 200 mg sorafenib as Nexavar®, film-coated tablets for oral administration, in a fasted state. IMP administrations (dosing) will be separated by wash-out periods of at least 14 days |
| Singel dose of DPH001 | Experimental | Drug: DPH0011 dose of 100 mg sorafenib as DPH001, HPMC capsuls for oral administration, in a fasted state. IMP administrations (dosing) will be separated by wash-out periods of at least 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willing and able to give written informed consent for participation in the trial, including consenting to the planned restrictions during the trial.
- Healthy male or female participant aged 18 to 65 years, inclusive.
- Body mass index (BMI) ≥18.5 and ≤30.0 kg/m2 at the time of the screening visit.
- Medically healthy participant without abnormal clinically significant medical/surgical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
- Female trial participants: Only female participants of non-childbearing potential will be considered eligible for participation. Female participants of non-childbearing potential are defined as:
Key exclusion criteria (28 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results or the participant's ability to participate in the trial.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of IMP.
- Malignancy within the past 5 years, with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the trial.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or HIV antigen and antibodies.
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 |
|---|---|---|
| DPH001100 mg | Drug | Singel dose of DPH001 |
| Nexavar (Sorafenib)200 mg | Drug | Single dose of Nexavar sorafenib |
Primary outcome
To compare the AUC (0-6h) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Time frame: From administration of study drug until 4 days
Blood samples will be collected in order to calculate a PK-profile. Area under the plasma concentration vs. time curve (AUC) from time 0 to 6 hours (AUC0 6h).
To compare the AUC (0-72 h) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Time frame: From administration of study drug until 4 days
Blood samples will be collected in order to calculate a PK-profile. Area under the plasma concentration vs. time curve (AUC) from time 0 to 72 hours (AUC 0-72h).
To compare the AUC (inf) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Time frame: From administration of study drug until 4 days
Blood samples will be collected in order to calculate a PK-profile. Area under the plasma concentration vs. time curve (AUC) from time 0 extrapolated to infinity (AUCinf).
To compare the Cmax of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Time frame: From administration of study drug until 4 days
Blood samples will be collected in order to calculate a PK-profile. Maximum observed plasma concentration (Cmax).
To compare the Tmax of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions.
Time frame: From administration of study drug until 4 days
Blood samples will be collected in order to calculate a PK-profile. Time to Cmax (Tmax).
34 secondary outcomes
Number of subjects with treatment-related adverse events assessed by frequency.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by seriouness.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by intensity.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by relationship to study treatment.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the systolic blood pressure.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the diastolic blood pressure.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter QRS.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter QT.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter PQ/PR.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter QTcF.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the ECG parameter heart rate.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the clinical chemistry parameters.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the hematology parameters.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the coagulation parameters.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the head.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the eyes.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the ears.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the nose.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the throat.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the skin.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the thyroid.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the neurological.
Time frame: From administration of study drug end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the lungs.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the cardiovascular.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the abdomen (liver and spleen).
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the lymphnodes.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with a clinical significant change from baseline in the physical examination of the extremities.
Time frame: From administration of study drug until end of trial (period 2 day 8).
Number of subjects with treatment-related adverse events assessed by frequency.
Time frame: From administration of study drug until 72 hours.
Number of subjects with treatment-related adverse events assessed by seriouness.
Time frame: From administration of study drug until 72 hours.
Number of subjects with treatment-related adverse events assessed by intensity.
Time frame: From administration of study drug until 72 hours.
Number of subjects with treatment-related adverse events assessed by relationship to study treatment.
Time frame: From administration of study drug until 72 hours.
Number of subjects with a clinical significant change from baseline in the clinical chemistry parameters.
Time frame: From administration of study drug until 72 hours.
Number of subjects with a clinical significant change from baseline in the hematology parameters.
Time frame: From administration of study drug until 72 hours.
Number of subjects with a clinical significant change from baseline in the coagulation parameters.
Time frame: From administration of study drug until 72 hours.
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 17 Mar 2025.
- Individual participant dataSharing planned: No
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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
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Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
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RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Björn Schultze, MD principal investigator
Clinical Trial Consultants (CTC), Dag Hammarskjölds väg 10B, 752 37 Uppsala, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DPH001 and Nexavar (Sorafenib) in people with Healthy, run by Disruptive Pharma at 1 site in Sweden.
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 12 inclusion and 28 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 17 Mar 2025. 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 Sweden. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
To compare the AUC (0-6h) of sorafenib after the administration of 100 mg DPH001 vs. 200 mg Nexavar® in fasted conditions. (time frame: From administration of study drug until 4 days). The study lists 5 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 17 Mar 2025.