A Phase 1 interventional study of CS0159 in Primary Sclerosing Cholangitis (PSC), sponsored by Cascade Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-18.
Sponsored by Cascade Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
The whole study includes 2 parts. Both the SAD study and MAD study are randomized, double-blinded, and placebo-controlled studies, conducted in healthy subjects, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics profiles of CS0159. The SAD part also involves a pilot food effect (FE) study, designed to assess the food effect on single-dose PK profile in healthy subjects.
A total of 48 healthy subjects will be allocated to 1 of 6 cohorts (cohort A1\~A6) in the SAD study, each cohort including 8 subjects (6 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single oral dose of CS0159 or placebo.To ensure the safety for all SAD cohorts (including A3 in both treatment periods).
The MAD study will enroll 32 healthy subjects, allocated to 1 of 4 cohorts (cohort B1\~B4) and each cohort including 8 participants (6 subjects will receive IND products and 2 receive placebo). Subjects will be randomly assigned to orally receive the IND product or placebo.
228 studies on the registry are indexed under Cholangitis; 32 are open to participants now.
This study's enrollment of 79 is above the median of 56 across 150 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →Cascade Pharmaceuticals, Inc is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in fasted state will receive CS0159 0.2 mg or placebo once on Day 1.
Drug: CS0159
Participants in fasted state will receive CS0159 0.6 mg or placebo once on Day 1.
Drug: CS0159
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.
Drug: CS0159
Participants in fasted state will receive CS0159 2 mg or placebo once on Day 1.
Drug: CS0159
Participants in fasted state will receive CS0159 4 mg or placebo once on Day 1.
Drug: CS0159
Participants in fasted state will receive CS0159 8 mg or placebo once on Day 1.
Drug: CS0159
Participants in fasted state will receive CS0159 0.4 mg or placebo once daily for a consecutive 14 days.
Drug: CS0159
Participants in fasted state will receive CS0159 1 mg or placebo once daily for a consecutive 14 days.
Drug: CS0159
Participants in fasted state will receive CS0159 2 mg or placebo once daily for a consecutive 14 days.
Drug: CS0159
Participants in fasted state will receive CS0159 4 mg or placebo once daily for a consecutive 14 days.
Drug: CS0159
Tablets administered orally
Also known as: Placebo
Single-Dose Pharmacokinetic (PK) Parameter
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞)
Time frame: Day 1 after dosing
Single-Dose Pharmacokinetic (PK) Parameter: (AUC0-last)
AUC from time zero to the time of the last measured concentration
Time frame: Day 1 after dosing
Single-Dose Pharmacokinetic (PK) Parameter: (Cmax)
Maximum observed plasma concentration
Time frame: Day 1 after dosing
Single-Dose Pharmacokinetic (PK) Parameter: (Tmax)
Time of the maximum observed plasma concentration
Time frame: Day 1 after dosing
Multiple-Dose PK Parameter
Maximum concentration during a dosing interval Ct_max
Time frame: Day 1 after dosing; day 14
Multiple-Dose PK Parameter: (Ct_min, Day 14)
Minimum concentration during a dosing interval
Time frame: Day 1 after dosing; day 14
Multiple-Dose PK Parameter: (AUCtau)
AUC over one dosing interval
Time frame: Day 1 after dosing; day 14
To characterize the safety and tolerability of single dose of CS0159
Incidence and severity of adverse events
Time frame: up to Day 31
To characterize the safety and tolerability of multiple doses of CS0159
Incidence and severity of adverse events
Time frame: up to Day 44
Pharmacodynamic (PD) Parameter: FGF19
fibroblast growth factor 19
Time frame: Day -1; day 1
Pharmacodynamic (PD) Parameter: C4
serum concentration
Time frame: Day -1; day 1
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Cascade Pharmaceuticals, Inc