Arthritis, RheumatoidPhase 1NCT03315494
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
A Phase 1 study testing SKI-O-703 capsule in people with Arthritis, Rheumatoid, run by Oscotec Inc. at 1 site in United States.
Trial summary
This double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- SKI-O-703 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2016to 21 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent for participation prior to completing any study procedures.
- Considered by investigator to be in good health, as judged by absence of clinically significant diseases and clinically significant abnormal values as determined by detailed medical history review, complete physical examination, and clinical laboratory evaluations.
- Male subjects and female subjects of non-childbearing potential 18-55 years old, inclusive, at time of screening.
- Females of non-childbearing potential are those who have been surgically sterile for at least 6 months or who have been postmenopausal for at least 2 years and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- Male subjects agree to use a condom with spermicide or to abstain from sexual intercourse for 90 days after dosing.
- Male subjects must agree not to donate sperm for 90 days after dosing.
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- Female subjects must have negative pregnancy tests at screening and on Day -1.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive, and body weight of ≥ 50 kg.
- Able to understand the study and any risks of participation and able to communicate with the investigator.
Who cannot join
- History of any clinically significant disease or disorder that may put the subject at risk due to study participation, impact the subject's ability to participate in the study, or influence the study results.
- History or presence of any gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any surgical or medical condition that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g. bariatric procedure).
- Any medical/surgical procedure or trauma within 4 weeks prior to Day -1 as determined by the investigator.
- Any clinically significant infection within 3 months prior to Day -1 as determined by the investigator.
- Any of the following abnormal laboratory values upon repeat testing at Screening or Check-in (Day -1):
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- Hemoglobin < lower limit of normal (LLN),
- Platelet count <LLN,
- Absolute neutrophil count <LLN or >upper limit of normal (ULN),
- Alanine aminotransferase or aspartate aminotransferase >ULN,
- Creatinine or blood urea nitrogen >ULN, or
- Any other clinically significant, in the opinion of the investigator, abnormal laboratory result.
- Use of concomitant medications from 30 days or 5 half-lives prior to Day -1 (whichever is longer) through completion of the End of Study (EOS) visit, including prescription medications, nutritional supplements, herbal remedies, and over-the-counter medications (note: use of vitamin supplements should be stopped at least 7 days prior to Screening through completion of the EOS visit).
- Receipt of any investigational medication within 30 days or 5 half-lives prior to Day -1, whichever is longer.
- Use of tobacco or nicotine-containing products within 30 days prior to Day -1 through the EOS visit.
- Use of CYP3A inducers and inhibitors (including St. John's wort) within 30 days prior to dosing.
- Intake of food or beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g. kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard), or charbroiled meats within 1 week prior to dosing.
- History of substance abuse, drug addiction, or alcoholism.
- Positive urine drug or urine alcohol test at Screening or Day -1 or unable to abstain from alcohol from 72 hours prior to study entry through the EOS visit.
- Unable to abstain from caffeine- and xanthine-containing products from 72 hours prior to dosing through discharge from the study center.
- Female subjects who are pregnant or lactating or have a positive pregnancy test at Screening or Day -1.
- Positive result at Screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibody or positive result for hepatitis B core antibody with a negative result for hepatitis B surface antigen.
- Recent (within the past 5 years) history of malignancy, except successfully treated basal cell carcinoma.
- High blood pressure, defined as >140 mm Hg systolic blood pressure or >90 mm Hg diastolic blood pressure upon repeat confirmation (repeated up to 4 times).
- Cardiac arrhythmias or clinically significant electrocardiogram (ECG) findings.
- Corrected QT interval >450 milliseconds or deemed clinically significant by the investigator (may be repeated for confirmation).
- Family history of long QT syndrome.
- Blood loss or blood donation >450 mL within 4 weeks prior to study drug dosing.
- History of sensitivity to drugs with chemical similarity to the study medication, its components, or the excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of SKI-O-703 in Healthy Volunteers
This double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers.
Read the detailed description
This is a double-blind, placebo-controlled study in healthy adult volunteers, to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-703. A total of 24 subjects are planned to participate in 3 cohorts (8 subjects each). In each cohort, 6 subjects will be randomly assigned to receive SKI-O-703 and 2 subjects will be randomly assigned to matching placebo. Dosing will be initiated with a 200 mg once daily (QD) dose cohort and escalated to 400 mg QD, under fasting conditions, for 7 days. In the third cohort, a 200 mg twice daily (BID) dose will be studied for 7 days. Evening dosing will occur 12 hours after the morning dose and will be preceded by fasting for at least 3 hours. After all 8 subjects in each cohort have received the study drug and been monitored, the decision to escalate to the next dose cohort will be made.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- SKI-O-703 capsule, Placebo capsule
- Keywords
- rheumatoid arthritis, healthy volunteers, moderate to severe
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKI-O-703 capsuleDrug
SKI-O-703 200 mg capsule with no inactive excipients.
Placebo capsuleDrug
Placebo 180 mg capsule filled with microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| SKI-O-703 200 mg (once daily) | Experimental | SKI-O-703 capsule (1 x 200 mg) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 400 mg (once daily) | Experimental | SKI-O-703 capsule (2 x 200 mg, once daily) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 200 mg (twice daily) | Experimental | SKI-O-703 capsule (1 x 200 mg twice daily) Receives: Drug: SKI-O-703 capsule |
| Placebo | Placebo comparator | Placebo capsule Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants (Healthy Volunteers) with reported adverse events receiving multiple dose of SKI-O-703 as assessment of safety and tolerability.
Safety and tolerability of SKI-O-703 as measured by subject incidence of treatment-related Adverse Events.
Measured: 21 days
Secondary outcomes (11)
Area under the concentration versus time curve within a dosing interval (AUC0-tau), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
AUC0-tau will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC0-t), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
AUC0-t will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Area under the concentration versus time curve within a dosing interval (AUC0-inf), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
AUC0-inf will be reported.
Measured: Day 7 only
Maximum observed concentration (Cmax), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Cmax will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Apparent oral clearance (CL/F), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
CL/F will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Terminal elimination rate constant (Kel), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Kel will be reported.
Measured: Day 7
Time to reach the maximum observed concentration, to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Tmax will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Apparent terminal elimination half-life (t1/2), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
t1/2 will be reported.
Measured: Day 7 only
Apparent volume of distribution (Vd/F), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Vd/F will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Metabolite ratio (Rmet), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Rmet will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Accumulation ratio based on AUC0-tau (RAUC), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
RAUC will be reported.
Measured: Days 1-7 (dosing), post-dose (days 8-10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start22 Sep 2016
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oscotec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315494
- Sponsor's protocol ID
- OSCO-P1202
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of SKI-O-703 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03315494
- Acronym / sponsor ID
- OSCO-P1202
- Conditions
- Arthritis, Rheumatoid
- Keywords
- rheumatoid arthritis, healthy volunteers, moderate to severe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oscotec Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 20 Oct 2017 (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 double-blind, placebo-controlled, multiple ascending dose study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of SKI-O-703 in healthy volunteers.
Detailed description
This is a double-blind, placebo-controlled study in healthy adult volunteers, to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-703. A total of 24 subjects are planned to participate in 3 cohorts (8 subjects each). In each cohort, 6 subjects will be randomly assigned to receive SKI-O-703 and 2 subjects will be randomly assigned to matching placebo. Dosing will be initiated with a 200 mg once daily (QD) dose cohort and escalated to 400 mg QD, under fasting conditions, for 7 days. In the third cohort, a 200 mg twice daily (BID) dose will be studied for 7 days. Evening dosing will occur 12 hours after the morning dose and will be preceded by fasting for at least 3 hours. After all 8 subjects in each cohort have received the study drug and been monitored, the decision to escalate to the next dose cohort will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SKI-O-703 200 mg (once daily) | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (1 x 200 mg) |
| SKI-O-703 400 mg (once daily) | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (2 x 200 mg, once daily) |
| SKI-O-703 200 mg (twice daily) | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (1 x 200 mg twice daily) |
| Placebo | Placebo comparator | Drug: Placebo capsulePlacebo capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Willing and able to provide written informed consent for participation prior to completing any study procedures.
- Considered by investigator to be in good health, as judged by absence of clinically significant diseases and clinically significant abnormal values as determined by detailed medical history review, complete physical examination, and clinical laboratory evaluations.
- Male subjects and female subjects of non-childbearing potential 18-55 years old, inclusive, at time of screening.
- Females of non-childbearing potential are those who have been surgically sterile for at least 6 months or who have been postmenopausal for at least 2 years and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- Male subjects agree to use a condom with spermicide or to abstain from sexual intercourse for 90 days after dosing.
Key exclusion criteria (29 listed)
- History of any clinically significant disease or disorder that may put the subject at risk due to study participation, impact the subject's ability to participate in the study, or influence the study results.
- History or presence of any gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any surgical or medical condition that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g. bariatric procedure).
- Any medical/surgical procedure or trauma within 4 weeks prior to Day -1 as determined by the investigator.
- Any clinically significant infection within 3 months prior to Day -1 as determined by the investigator.
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 |
|---|---|---|
| SKI-O-703 capsuleSKI-O-703 200 mg capsule with no inactive excipients. | Drug | SKI-O-703 200 mg (once daily), SKI-O-703 200 mg (twice daily), SKI-O-703 400 mg (once daily) |
| Placebo capsulePlacebo 180 mg capsule filled with microcrystalline cellulose. | Drug | Placebo |
Primary outcome
Number of participants (Healthy Volunteers) with reported adverse events receiving multiple dose of SKI-O-703 as assessment of safety and tolerability.
Time frame: 21 days
Safety and tolerability of SKI-O-703 as measured by subject incidence of treatment-related Adverse Events.
11 secondary outcomes
Area under the concentration versus time curve within a dosing interval (AUC0-tau), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC0-t), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Area under the concentration versus time curve within a dosing interval (AUC0-inf), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Day 7 only
Maximum observed concentration (Cmax), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Apparent oral clearance (CL/F), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Terminal elimination rate constant (Kel), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Day 7
Time to reach the maximum observed concentration, to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Apparent terminal elimination half-life (t1/2), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Day 7 only
Apparent volume of distribution (Vd/F), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Metabolite ratio (Rmet), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
Accumulation ratio based on AUC0-tau (RAUC), to investigate pharmacokinetic profiles of SKI-O-592 (the free base of SKI-O-703) and its metabolites (M2 and M4) in healthy volunteers.
Time frame: Days 1-7 (dosing), post-dose (days 8-10).
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 Oct 2017.
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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 SKI-O-703 capsule in people with Arthritis, Rheumatoid, 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 9 inclusion and 29 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 Oct 2017. 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. Some participants in this study may receive a placebo. 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?
Number of participants (Healthy Volunteers) with reported adverse events receiving multiple dose of SKI-O-703 as assessment of safety and tolerability. (time frame: 21 days). 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 Oct 2017.