Clinical Trials/NCT03315494

NCT03315494

Completed

Phase 1

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

Oscotec Inc.1 site in 1 country24 target enrollmentSeptember 22, 2016

ConditionsArthritis, Rheumatoid

InterventionsSKI-O-703 capsule Placebo capsule

DrugsSKI-O-703 capsule Placebo capsule

Overview

Phase: Phase 1
Intervention: SKI-O-703 capsule
Conditions: Arthritis, Rheumatoid
Sponsor: Oscotec Inc.
Enrollment: 24
Locations: 1
Primary Endpoint: Number of participants (Healthy Volunteers) with reported adverse events receiving multiple dose of SKI-O-703 as assessment of safety and tolerability.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

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.

Registry

clinicaltrials.gov

Start Date

September 22, 2016

End Date

December 21, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oscotec Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•Female subjects must have negative pregnancy tests at screening and on Day -
•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.

Exclusion Criteria

•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):
•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,

Arms & Interventions

SKI-O-703 200 mg (once daily)

SKI-O-703 capsule (1 x 200 mg)

Intervention: SKI-O-703 capsule

SKI-O-703 400 mg (once daily)

SKI-O-703 capsule (2 x 200 mg, once daily)

Intervention: SKI-O-703 capsule

SKI-O-703 200 mg (twice daily)

SKI-O-703 capsule (1 x 200 mg twice daily)

Intervention: SKI-O-703 capsule

Placebo

Placebo capsule

Intervention: Placebo capsule

Outcomes

Primary Outcomes

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.

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.(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.(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.(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.(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.(Days 1-7 (dosing), post-dose (days 8-10).)
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.(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.(Day 7)
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.(Day 7 only)
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.(Days 1-7 (dosing), post-dose (days 8-10).)
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.(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.(Days 1-7 (dosing), post-dose (days 8-10).)