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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03976687




Registration number
NCT03976687
Ethics application status
Date submitted
4/06/2019
Date registered
6/06/2019

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
Scientific title
A Phase 1b, Open-label Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FXR Agonist/Modulator EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
Secondary ID [1] 0 0
EYP001-107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH - Nonalcoholic Steatohepatitis 0 0
Healthy 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EYP001a

Experimental: 1: EYP001a Dose A - Dose A once daily morning dose

Experimental: 2: EYP001a Dose B - Dose B once daily morning dose

Experimental: 3: EYP001a Dose C - Dose C twice daily - first dose morning dose and second dose 3 hours post first dose


Treatment: Drugs: EYP001a
Oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum plasma concentration (Cmax) of EYP001a
Timepoint [1] 0 0
Day 2 through day 9
Primary outcome [2] 0 0
Time to reach maximum concentration (Tmax) after EYP001a administration
Timepoint [2] 0 0
Day 2 through day 9
Primary outcome [3] 0 0
Area under the concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-10h and AUClast) of EYP001a
Timepoint [3] 0 0
Day 2 through day 9
Primary outcome [4] 0 0
Area under the concentration-time curve (AUC) and Maximum plasma concentration (Cmax) ratios
Timepoint [4] 0 0
Day 2 through day 9
Primary outcome [5] 0 0
Type and frequencies of Adverse events
Timepoint [5] 0 0
Day 1 through day 16
Secondary outcome [1] 0 0
Bile acid precursor : C4 (7ahydroxy-4-cholesten-3-one)
Timepoint [1] 0 0
Day 2 through day 9
Secondary outcome [2] 0 0
Bile acid precursor : Fibroblast growth factor 19 (FGF19)
Timepoint [2] 0 0
Day 2 through day 9
Secondary outcome [3] 0 0
Total Bile acids (secondary and primary)
Timepoint [3] 0 0
Day 1 through day 9

Eligibility
Key inclusion criteria
1. Have given voluntary written informed consent;
2. Male/female participants aged 18 years to 75 years with a Body Mass Index (BMI) = 25 kg/m² and = 45 kg/m² at screening.
3. A female participant is eligible to participate in this study if:

1. She is of non-childbearing potential (defined as females with a documented tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as 12 months of spontaneous amenorrhea and follicle stimulating hormone level within the laboratory's reference range for postmenopausal females). A post-menopausal female receiving hormone replacement therapy (HRT) other than hormone replacement patches who is willing to discontinue hormone therapy 28 days before study drug dosing and agrees to remain off hormone replacement therapy for the duration of the study may be eligible for study participation. A post-menopausal female using Hormone Replacement patches who is willing to discontinue the patch 48 hours before Check in on Day -1 and until the completion of her End of Study visit is eligible for study participation.
2. She is of childbearing potential and is non-pregnant or non-lactating and willing to use adequate contraception from screening until 3 months after the End of Study visit. Adequate contraception is defined as a progesterone only intra uterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence in accordance with the lifestyle of the participant is acceptable.
3. She is of childbearing potential and is non-pregnant or non-lactating and taking the combined oral contraceptive pill and willing to discontinue the combined oral contraceptive pill 7 days prior to check in on Day -1 and until the completion of her End of Study visit and use adequate contraception from the day of cessation. Adequate contraception is defined as a diaphragm or cervical cap together with a condom. Also, total abstinence in accordance with the lifestyle of the participant is acceptable.
4. Have Alanine Aminotransferase (ALT) >1.5 upper limit of normal (ULN) during screening period.
5. Fibroscan® Vibration-Controlled Transient Elastography (VTCE) liver stiffness (liver stiffness measure (LSM) for >8.5 kPa) and steatosis (Controlled Attenuation Parameter (CAP) =250 decibels per meter (dB/m)).
6. Normal liver function at screening for alkaline phosphatase (ALP), Total Bilirubin (TBL), conjugated Bilirubin, platelets, International normalized ratio (INR).

Nota Bene: Criteria 4 and 5 do not apply to healthy volunteers.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Employee of a contract research organization (CRO) participating in this study or the Sponsor.
2. Patients with known non-NASH chronic liver disease (alcohol, autoimmune, Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), active hepatitis C virus (HCV)).
3. Female with childbearing potential if no dual safe anti-contraception method can be provided.
4. Renal impairment (participants with an estimated glomerular filtration rate (eGFR) computed from the Modification of Diet in Renal Disease (MDRD) formula of < 60ml/min/1.73m² are excluded). Note: participants with mild renal impairment (eGFR >60 ml/min and =90 ml/min) are eligible.
5. Has clinically relevant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.
6. Has any known pre-existing medical or psychiatric condition that could interfere with the participant's ability to provide informed consent or participate in study conduct, or that may confound study findings.
7. Has a history of clinically significant gastrointestinal (GI) disease, especially peptic ulcerations, GI bleeding, ulcerative colitis, Crohn's disease or Inflammatory Bowel Syndrome, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results.
8. Has participated in any drug study within 60 days prior to the first drug administration in the current study.
9. Has had major surgery within 30 days prior to the first drug administration.
10. Concomitant use of not listed drugs after discussion with Sponsor not admitted.
11. Has a history of relevant drug and/or food allergies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/05/2020
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ENYO Pharma clinical site - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Enyo Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03976687