Rheumatoid ArthritisPhase 1NCT02717988
Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers
A Phase 1 study testing SKI-O-703 capsule in people with Rheumatoid Arthritis, run by Oscotec Inc. at 1 site in United States.
Trial summary
This double-blind, placebo-controlled, single ascending dose study is designed to demonstrate safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers. The results of this study will guide selection of dose levels for future multiple dose studies in healthy volunteers and adult patients with… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 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 the investigator to be in good health as determined by the absence of clinically significant diseases or clinically significant abnormal values as determined by a detailed medical history review, complete physical examination, and clinical laboratory assessments. Clinical significance for any out-of-range laboratory test results will be determined by the principal investigator
- Male subjects and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
- Female subjects of non-childbearing potential are those who are surgically sterile at least 6 months or postmenopausal at least 2 years and have follicle-stimulating hormone serum levels consistent with postmenopausal status.
- Male subjects must agree to use a condom with spermicide or 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 serum pregnancy test results at Screening and Day -1
- Subject must have a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, and weight ≥50 kg
- Subject must be able to understand the study and any risks to 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 if he/she participates in the study, might affect 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 (ADME) of drugs
- Any surgical or medical conditions possibly affecting drug ADME (eg, bariatric procedure)
- Any medical/surgical procedure or trauma within 4 weeks of Day -1 as determined by the investigator
- Any clinically significant infection within 3 months of Day -1 as determined by the investigator
- Any of the following abnormal laboratory values upon repeat testing at Screening or check-in:
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- Hemoglobin <the lower limit of normal (LLN)
- Platelet count <LLN
- Absolute neutrophil count <LLN or >the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >ULN
- Creatinine or blood urea nitrogen >ULN
- Other clinically significant abnormal laboratory results in the opinion of the investigator
- Use of concomitant medications from 30 days or 5 half-lives prior to Day -1 (whichever is longer), including prescription medications, nutritional supplements, herbal remedies, and over-the-counter medications
- 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 and through the End-of-Study visit
- Use of cytochrome P450 3A isozyme (CYP3A) inducers and inhibitors (including St. John's wort) within 30 days of dosing
- Food or beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (eg, kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), and charbroiled meats within 1 week prior to dosing
- History of substance abuse, drug addiction, or alcoholism
- Positive urine drug or urine alcohol test result at screening or Day -1 or unable to abstain from alcohol from 72 hours prior to study entry to the End-of-Study visit
- Unable to abstain from caffeine and xanthine-containing products from 72 hours prior to dosing through discharge from the study site
- Female subjects who are pregnant or lactating or have a positive serum pregnancy test result at Screening
- Positive test results at Screening for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, or hepatitis B core antibody and negative for HBsAg
- Recent (past 5 years) history of malignancy except successfully treated basal cell carcinoma
- High blood pressure, defined as >140 millimeters of mercury (mm Hg) systolic blood pressure or >90 mm Hg diastolic blood pressure upon repeat confirmation
- Cardiac arrhythmias or clinically significant ECG findings upon repeat confirmation by the investigator
- Corrected QT interval (QTc) >450 milliseconds or deemed clinically significant by the investigator
- Family history of long QT syndrome
- Blood loss or blood donation >450 mL within 4 weeks of study drug dosing
- History of sensitivity to drugs with chemical similarity to the study drug, its components, or excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers
This double-blind, placebo-controlled, single ascending dose study is designed to demonstrate safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers. The results of this study will guide selection of dose levels for future multiple dose studies in healthy volunteers and adult patients with moderately to severely active rheumatoid arthritis.
Read the detailed description
This is a double-blind, placebo-controlled study in healthy adult volunteers that will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ascending single doses of SKI-O-703. A total of 48 subjects are planned to participate in 6 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 in the 50 mg dose cohort and sequentially escalated to the 100 mg, 200 mg, 400 mg, 600 mg, and 800 mg cohorts.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SKI-O-703 capsule, Placebo capsule
- Keywords
- rheumatoid arthritis, healthy volunteers, moderately to severely active
- 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 25 mg capsule or 200 mg capsule without excipient
Placebo capsuleDrug
Placebo 180 mg capsule filled with microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| SKI-O-703 50 mg | Experimental | SKI-O-703 capsule (2x25 mg) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 100 mg | Experimental | SKI-O-703 capsule (4x25 mg) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 200 mg | Experimental | SKI-O-703 capsule (1x200 mg) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 400 mg | Experimental | SKI-O-703 capsule (2x200 mg) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 600 mg | Experimental | SKI-O-703 capsule (3x200 mg) Receives: Drug: SKI-O-703 capsule |
| SKI-O-703 800 mg | Experimental | SKI-O-703 capsule (4x200 mg) 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 single 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: 28 days
Secondary outcomes (12)
Area under the concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-t) for estimating the pharmacokinetic parameters of SKI-O-592 (the free base of SKI-O-703) and its metabolites.
AUC0-t will be reported
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
AUC0-inf will be reported
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Maximum observed plasma concentration (Cmax)
Cmax will be reported
Measured: Days 0 (pre-dose), 1 (dosing), and post-dose at days 2, 3 and 4
Time to reach the maximum observed plasma concentration (Tmax)
Tmax will be reported
Measured: Day 0 (pre-dose), Day1 (dosing), and post-dose at days 2, 3 and 4
Apparent terminal elimination half-life (T1/2)
T1/2 will be reported
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Apparent volume of distribution (Vd/F) (SKI-O-592, free base of SKI-O-703)
Vd/F will be reported
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Apparent oral clearance (CL/F) (SKI-O-592 only)
CL/F will be reported.
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Terminal elimination rate constant (Kel)
Kel will be reported.
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Mean residence time (MRT)
MRT will be reported.
Measured: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Metabolite ratio (Rmet), calculated as AUC0-t (metabolite) / AUC0-t (parent) (metabolites M1, M2 and M4 only).
Rmet will be reported.
Measured: Day 0 (pre-dose), Day 1 (dosing) and post-dose at Days 2, 3 and 4
Renal clearance (SKI-O-592, free base of SKI-O-703 only)
Renal clearance will be reported.
Measured: Day 1 (dosing), and post-dose at days 2, 3 and 4
Amount of drug excreted in urine over the collection intervals of 0 to 4 hours (Ae0-4), 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours, and 48 to 72 hours post dose.
Ae will be reported
Measured: Day 1 (dosing), and post-dose at days 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT02717988
- Sponsor's protocol ID
- OSCO-P1201
- Status last verified
- Oct 2017
- First submitted
- 4 Mar 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02717988
- Acronym / sponsor ID
- OSCO-P1201
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, healthy volunteers, moderately to severely active
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Oscotec Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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, single ascending dose study is designed to demonstrate safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers. The results of this study will guide selection of dose levels for future multiple dose studies in healthy volunteers and adult patients with moderately to severely active rheumatoid arthritis.
Detailed description
This is a double-blind, placebo-controlled study in healthy adult volunteers that will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ascending single doses of SKI-O-703. A total of 48 subjects are planned to participate in 6 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 in the 50 mg dose cohort and sequentially escalated to the 100 mg, 200 mg, 400 mg, 600 mg, and 800 mg cohorts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| SKI-O-703 50 mg | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (2x25 mg) |
| SKI-O-703 100 mg | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (4x25 mg) |
| SKI-O-703 200 mg | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (1x200 mg) |
| SKI-O-703 400 mg | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (2x200 mg) |
| SKI-O-703 600 mg | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (3x200 mg) |
| SKI-O-703 800 mg | Experimental | Drug: SKI-O-703 capsuleSKI-O-703 capsule (4x200 mg) |
| 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 the investigator to be in good health as determined by the absence of clinically significant diseases or clinically significant abnormal values as determined by a detailed medical history review, complete physical examination, and clinical laboratory assessments. Clinical significance for any out-of-range laboratory test results will be determined by the principal investigator
- Male subjects and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
- Female subjects of non-childbearing potential are those who are surgically sterile at least 6 months or postmenopausal at least 2 years and have follicle-stimulating hormone serum levels consistent with postmenopausal status.
- Male subjects must agree to use a condom with spermicide or 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 if he/she participates in the study, might affect 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 (ADME) of drugs
- Any surgical or medical conditions possibly affecting drug ADME (eg, bariatric procedure)
- Any medical/surgical procedure or trauma within 4 weeks of Day -1 as determined by the investigator
- Any clinically significant infection within 3 months of 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 25 mg capsule or 200 mg capsule without excipient | Drug | SKI-O-703 100 mg, SKI-O-703 200 mg, SKI-O-703 400 mg, SKI-O-703 50 mg, SKI-O-703 600 mg, SKI-O-703 800 mg |
| Placebo capsulePlacebo 180 mg capsule filled with microcrystalline cellulose | Drug | Placebo |
Primary outcome
Number of participants (Healthy Volunteers) with reported adverse events receiving single dose of SKI-O-703 as assessment of safety and tolerability.
Time frame: 28 days
Safety and tolerability of SKI-O-703 as measured by subject incidence of treatment-related Adverse Events.
12 secondary outcomes
Area under the concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-t) for estimating the pharmacokinetic parameters of SKI-O-592 (the free base of SKI-O-703) and its metabolites.
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Maximum observed plasma concentration (Cmax)
Time frame: Days 0 (pre-dose), 1 (dosing), and post-dose at days 2, 3 and 4
Time to reach the maximum observed plasma concentration (Tmax)
Time frame: Day 0 (pre-dose), Day1 (dosing), and post-dose at days 2, 3 and 4
Apparent terminal elimination half-life (T1/2)
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Apparent volume of distribution (Vd/F) (SKI-O-592, free base of SKI-O-703)
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Apparent oral clearance (CL/F) (SKI-O-592 only)
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Terminal elimination rate constant (Kel)
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Mean residence time (MRT)
Time frame: Day 0 (pre-dose), Day 1 (dosing), and post-dose at days 2, 3 and 4
Metabolite ratio (Rmet), calculated as AUC0-t (metabolite) / AUC0-t (parent) (metabolites M1, M2 and M4 only).
Time frame: Day 0 (pre-dose), Day 1 (dosing) and post-dose at Days 2, 3 and 4
Renal clearance (SKI-O-592, free base of SKI-O-703 only)
Time frame: Day 1 (dosing), and post-dose at days 2, 3 and 4
Amount of drug excreted in urine over the collection intervals of 0 to 4 hours (Ae0-4), 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours, and 48 to 72 hours post dose.
Time frame: Day 1 (dosing), and post-dose at days 2, 3 and 4
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 28 Feb 2018.
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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 Rheumatoid Arthritis, 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 28 Feb 2018. 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 single dose of SKI-O-703 as assessment of safety and tolerability. (time frame: 28 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 28 Feb 2018.