Healthy VolunteersEarly Phase 1NCT05042986
A Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
A Early Phase 1 study testing .[14C]-SKI-O-703 in people with Healthy Volunteers, run by Oscotec Inc. at 1 site in United States.
Trial summary
This will be a Phase I, open-label, nonrandomized, single dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- .[14C]-SKI-O-703
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 29 Sep 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, 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'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 will agree to use contraception as detailed in the protocol
- 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.
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).
- 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). Cholecystectomy is not allowed.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Alcohol consumption of > 21 units per week. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen at screening or positive alcohol urine test result or positive urine drug screen at check-in.
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- Positive hepatitis panel and/or positive human immunodeficiency virus test (Appendix 2).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 5 half-lives of the drug, if known, or 30 days, whichever is longer, prior to last dose of the previous study.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, cytochrome P450 1A2 and UGT1A1 inhibitors/inducers, or elimination 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 at screening or 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.
- Have previously completed or withdrawn from this study or any other study investigating SKI-O-703, and have previously received SKI-O-703.
- 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 more than 3 radiolabeled drug studies in the last 12 months (previous study to be at least 4 months prior to check-in to the study site where exposures are known to the investigator or 6 months prior to check-in to the study site for a radiolabeled drug study where exposures are not known to the investigator). The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per United States Title 21 CFR 361.1.5
- 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 States1 site
Labcorp Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
This will be a Phase I, open-label, nonrandomized, single dose study in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8. On the morning of Day 1, all subjects will receive a single oral dose of [14C]-SKI-O-703. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥ 90% mass balance recovery, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site up to Day 15.
Read the detailed description
SKI-O-703 is being developed by Oscotec Inc. and is currently being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of patients with persistent and chronic immune thrombocytopenia. SKI-O-592 (the free base of SKI-O-703) has demonstrated high selectivity and potency against spleen tyrosine kinase in a biochemical assay. For immunoreceptor activation linked to SYK, the effect of SKI-O-592 on the anti-inflammatory response consisting of tumor necrosis factor alpha, β-hexosaminidase, and CD69 expression was greater than the effects of first-generation SYK inhibitors (eg, R406) in several immune cell lines and in human primary cells. This anti-inflammatory activity was responsible for the selective inhibition of p-SYK (Y525/526), which led to the sequential inhibition of downstream effectors. In vitro studies revealed excellent SYK selectivity of SKI-O-592 that led to no inhibition of SYK-independent signal pathways, indicating that SKI-O-592 shows more potent anti-inflammatory activity to allow continuous administration of SKI-O-703 compared with the first-generation SYK inhibitors. SKI-O-703 is currently not approved or marketed in any country.
- Conditions
- Healthy Volunteers
- Being tested
- .[14C]-SKI-O-703
- Keywords
- Healthy Male Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
.[14C]-SKI-O-703Drug
Single oral dose of 200 mg (100 μCi in 200 mg salt [0.5 μCi/mg as salt], equivalent to 100 μCi in 142 mg active [0.7 μCi/mg as active]) of [14C]-SKI-O-703 containing approximately 100 μCi of [14C]-SKI-O-703 per capsule after an overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Capsule | Experimental | Single oral dose of 200 mg (100 μCi in 200 mg salt [0.5 μCi/mg as salt], equivalent to 100 μCi in 142 mg active [0.7 μCi/mg as active]) of [14C]-SKI-O-703 containing approximately 100 μCi of [14C]-SKI-O-703 per capsule after an overnight fast. Receives: Drug: .[14C]-SKI-O-703 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (Area under creative curve) from time zero to infinity (AUC0-∞)
Measured: Baseline through day 43
AUC from time zero to the last quantifiable concentration (AUC0-tlast)
Measured: Baseline through day 43
Time to Cmax
Measured: Baseline through day 43
Time to tmax
Measured: Baseline through day 43
Time to t1/2
Measured: Baseline through day 43
Apparent total clearance (CL/F; plasma SKI-O-592 only)
Measured: Baseline through day 43
Apparent volume of distribution (Vz/F; plasma SKI-O-592 only)
Measured: Baseline through day 43
AUC0-∞ of plasma SKI-O-592 relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma SKI-O-592/Total Radioactivity Ratio)
Measured: Baseline through day 43
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0-∞ Blood/Plasma Ratio
Measured: Baseline through day 43
Amount of SKI-O-592 and total radioactivity excreted in urine (Aeu)
Measured: Baseline through day 43
Cumulative Aeu of SKI-O-592 and total radioactivity
Measured: Baseline through day 43
Percentage of SKI-O-592 excreted in urine (feu) and total radioactivity
Measured: Baseline through day 43
Cumulative feu of SKI-O-592 and total radioactivity
Measured: Baseline through day 43
Renal clearance (CLR; SKI-O-592 only)
Measured: Baseline through day 43
Amount of total radioactivity excreted in feces (Aef)
Measured: Baseline through day 43
Cumulative radioactivity Aef
Measured: Baseline through day 43
Percentage of total radioactivity excreted in feces (fef)
Measured: Baseline through day 43
Cumulative radioactivity fef
Measured: Baseline through day 43
Secondary outcomes (7)
Metabolic profile of SKI-O-592
Measured: Baseline through day 43
Identifications of SKI-O-592 metabolites
Measured: Baseline through day 43
Number and severity of AEs
Measured: Screening through day 43
incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Measured: Screening through day 43
Incidence of abnormal 12-Lead ECG
Measured: Screening through day 43
Incidence of abnormal vital sign measurements
Measured: Screening through day 43
Incidence of abnormal physical examination
Measured: Screening through day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start10 Aug 2021
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oscotec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Chair, Study chair, Oscotec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042986
- Sponsor's protocol ID
- OCSO-P1204
- Status last verified
- Apr 2022
- First submitted
- 3 Sep 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-SKI-O-703 Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05042986
- Acronym / sponsor ID
- OCSO-P1204
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Male Subjects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Oscotec Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 13 Sep 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 will be a Phase I, open-label, nonrandomized, single dose study in healthy male subjects.
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the study site on Day -1 and be confined to the study site until at least Day 8. On the morning of Day 1, all subjects will receive a single oral dose of [14C]-SKI-O-703. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, ≥ 90% mass balance recovery, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods. If discharge criteria are not met by Day 8, subjects will remain in the study site up to Day 15.
Detailed description
SKI-O-703 is being developed by Oscotec Inc. and is currently being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis and for the treatment of patients with persistent and chronic immune thrombocytopenia. SKI-O-592 (the free base of SKI-O-703) has demonstrated high selectivity and potency against spleen tyrosine kinase in a biochemical assay. For immunoreceptor activation linked to SYK, the effect of SKI-O-592 on the anti-inflammatory response consisting of tumor necrosis factor alpha, β-hexosaminidase, and CD69 expression was greater than the effects of first-generation SYK inhibitors (eg, R406) in several immune cell lines and in human primary cells. This anti-inflammatory activity was responsible for the selective inhibition of p-SYK (Y525/526), which led to the sequential inhibition of downstream effectors. In vitro studies revealed excellent SYK selectivity of SKI-O-592 that led to no inhibition of SYK-independent signal pathways, indicating that SKI-O-592 shows more potent anti-inflammatory activity to allow continuous administration of SKI-O-703 compared with the first-generation SYK inhibitors. SKI-O-703 is currently not approved or marketed in any country.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Dose Capsule | Experimental | Drug: .[14C]-SKI-O-703Single oral dose of 200 mg (100 μCi in 200 mg salt [0.5 μCi/mg as salt], equivalent to 100 μCi in 142 mg active [0.7 μCi/mg as active]) of [14C]-SKI-O-703 containing approximately 100 μCi of [14C]-SKI-O-703 per capsule after an overnight fast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- In good health, 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'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 will agree to use contraception as detailed in the protocol
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Key exclusion criteria (20 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).
- 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). Cholecystectomy is not allowed.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Alcohol consumption of > 21 units per week. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
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]-SKI-O-703Single oral dose of 200 mg (100 μCi in 200 mg salt [0.5 μCi/mg as salt], equivalent to 100 μCi in 142 mg active [0.7 μCi/mg as active]) of [14C]-SKI-O-703 containing approximately 100 μCi of [14C]-SKI-O-703 per capsule after an overnight fast. | Drug | Single Dose Capsule |
Primary outcome
AUC (Area under creative curve) from time zero to infinity (AUC0-∞)
Time frame: Baseline through day 43
AUC from time zero to the last quantifiable concentration (AUC0-tlast)
Time frame: Baseline through day 43
Time to Cmax
Time frame: Baseline through day 43
Time to tmax
Time frame: Baseline through day 43
Time to t1/2
Time frame: Baseline through day 43
Apparent total clearance (CL/F; plasma SKI-O-592 only)
Time frame: Baseline through day 43
Apparent volume of distribution (Vz/F; plasma SKI-O-592 only)
Time frame: Baseline through day 43
AUC0-∞ of plasma SKI-O-592 relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma SKI-O-592/Total Radioactivity Ratio)
Time frame: Baseline through day 43
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0-∞ Blood/Plasma Ratio
Time frame: Baseline through day 43
Amount of SKI-O-592 and total radioactivity excreted in urine (Aeu)
Time frame: Baseline through day 43
Cumulative Aeu of SKI-O-592 and total radioactivity
Time frame: Baseline through day 43
Percentage of SKI-O-592 excreted in urine (feu) and total radioactivity
Time frame: Baseline through day 43
Cumulative feu of SKI-O-592 and total radioactivity
Time frame: Baseline through day 43
Renal clearance (CLR; SKI-O-592 only)
Time frame: Baseline through day 43
Amount of total radioactivity excreted in feces (Aef)
Time frame: Baseline through day 43
Cumulative radioactivity Aef
Time frame: Baseline through day 43
Percentage of total radioactivity excreted in feces (fef)
Time frame: Baseline through day 43
Cumulative radioactivity fef
Time frame: Baseline through day 43
7 secondary outcomes
Metabolic profile of SKI-O-592
Time frame: Baseline through day 43
Identifications of SKI-O-592 metabolites
Time frame: Baseline through day 43
Number and severity of AEs
Time frame: Screening through day 43
incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Time frame: Screening through day 43
Incidence of abnormal 12-Lead ECG
Time frame: Screening through day 43
Incidence of abnormal vital sign measurements
Time frame: Screening through day 43
Incidence of abnormal physical examination
Time frame: Screening through day 43
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 20 Apr 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Study Chair study chair
Oscotec Inc.
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 .[14C]-SKI-O-703 in people with Healthy Volunteers, run by Oscotec Inc. 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 20 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 20 Apr 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 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?
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?
AUC (Area under creative curve) from time zero to infinity (AUC0-∞) (time frame: Baseline through day 43). The study lists 18 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 20 Apr 2022.