AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Study Details
Study Description
Brief Summary
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1: TERN-201 dose level 1 Orally administered. |
Drug: TERN-201
Investigational drug
|
Placebo Comparator: Part 1: Placebo Orally Administered |
Other: Placebo
Matching placebo
|
Experimental: Part 2: TERN-201 dose level 2 Orally administered |
Drug: TERN-201
Investigational drug
|
Placebo Comparator: Part 2: Placebo Orally administered |
Other: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- Subject incidence of adverse events for TERN-201 versus placebo [16 weeks]
Secondary Outcome Measures
- Plasma concentration of TERN-201- AUC [12 weeks]
Area under the curve
- Plasma concentration of TERN-201- Cmax [12 weeks]
Maximum observed concentration
- Plasma concentration of TERN-201- Tmax [12 weeks]
Time to reach maximum measured plasma concentration
- Plasma concentration of TERN-201- T1/2 [12 weeks]
Determination of half-life
- Percent Change from baseline in plasma VAP-1/SSAO activity [12 weeks]
- Urine concentration of TERN-201- CLr [Day 1]
Renal clearance
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, 18 to 75 years of age
-
Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
-
Presumed NASH based on clinical characteristics or prior liver biopsy
-
ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
-
MRI-cT1 value> 800 ms
-
Written informed consent
Exclusion Criteria:
-
History or clinical evidence of chronic liver diseases other than NAFLD
-
History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
-
History of liver transplant, or current placement on a liver transplant list
-
Weight loss of > 5% total body weight within 3 months prior to Screening
Note: Other protocol-defined inclusion/exclusion criteria that apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Terns Clinical Study Site 1018 | Tucson | Arizona | United States | 85712 |
2 | Terns Clinical Study Site 1024 | Tucson | Arizona | United States | 85712 |
3 | Terns Clinical Study Site 1004 | Coronado | California | United States | 92117 |
4 | Terns Clinical Study Site 1039 | Los Angeles | California | United States | 90048 |
5 | Terns Clinical Study Site 1001 | Panorama City | California | United States | 91402 |
6 | Terns Clinical Study Site 1040 | Rialto | California | United States | 92377 |
7 | Terns Clinical Study Site 1013 | San Diego | California | United States | 92093 |
8 | Terns Clinical Study Site 1010 | Bastrop | Louisiana | United States | 71220 |
9 | Terns Clinical Study Site 1006 | San Antonio | Texas | United States | 78215 |
10 | Terns Clinical Study Site 1003 | San Antonio | Texas | United States | 78229 |
11 | Terns Clinical Study Site 1019 | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Terns, Inc.
Investigators
- Study Director: clinicaltrials@ternspharma.com, Terns, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TERN201-1007