Your session is about to expire
← Back to Search
Other
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159
Phase 1
Waitlist Available
Led By Kathleen Doisy, MD
Research Sponsored by Cascade Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 after dosing; day 14
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called CS0159 in healthy people to see if it is safe and how it behaves in their bodies. Researchers will study how the drug is absorbed, distributed, metabolized, and excreted, as well as its effects on the body.
Eligible Conditions
- Primary Sclerosing Cholangitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 after dosing; day 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 after dosing; day 14
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Multiple-Dose PK Parameter
Multiple-Dose PK Parameter: (AUCtau)
Multiple-Dose PK Parameter: (Ct_min, Day 14)
+6 moreSecondary study objectives
Pharmacodynamic (PD) Parameter: C4
Pharmacodynamic (PD) Parameter: FGF19
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
10Treatment groups
Experimental Treatment
Group I: Cohort B4: 4mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 4 mg or placebo once daily for a consecutive 14 days.
Group II: Cohort B3: 2 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 2 mg or placebo once daily for a consecutive 14 days.
Group III: Cohort B2: 1 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 1 mg or placebo once daily for a consecutive 14 days.
Group IV: Cohort B1: 0.4 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 0.4 mg or placebo once daily for a consecutive 14 days.
Group V: Cohort A6: 8 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 8 mg or placebo once on Day 1.
Group VI: Cohort A5: 4 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 4 mg or placebo once on Day 1.
Group VII: Cohort A4: 2 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 2 mg or placebo once on Day 1.
Group VIII: Cohort A3: 1 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 1 mg or placebo once on Day 1 followed by a 7-day washout period then given in 1 mg tablet (in fed state) on Day 8.
Group IX: Cohort A2: 0.6 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 0.6 mg or placebo once on Day 1.
Group X: Cohort A1: 0.2 mgExperimental Treatment1 Intervention
Participants in fasted state will receive CS0159 0.2 mg or placebo once on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CS0159
2022
Completed Phase 1
~120
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Cascade Pharmaceuticals, IncLead Sponsor
7 Previous Clinical Trials
426 Total Patients Enrolled
CovanceIndustry Sponsor
120 Previous Clinical Trials
12,888 Total Patients Enrolled
Kathleen Doisy, MDPrincipal InvestigatorLabcorp Clinical Research Unit, Inc.
1 Previous Clinical Trials
210 Total Patients Enrolled