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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03381287




Registration number
NCT03381287
Ethics application status
Date submitted
18/12/2017
Date registered
21/12/2017
Date last updated
3/03/2023

Titles & IDs
Public title
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
Scientific title
A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia
Secondary ID [1] 0 0
HTD1801.PCT004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HTD1801 Tablets, 500 mg
Treatment: Drugs - HTD1801 Tablets, 1000 mg
Treatment: Drugs - HTD1801 Tablets, 2000 mg
Treatment: Drugs - Placebo to match 500 mg HTD1801
Treatment: Drugs - Placebo to match 1000 mg HTD1801
Treatment: Drugs - Placebo to match 2000 mg HTD1801

Experimental: HTD1801 250 mg BID - Subjects received 500 mg/day HTD1801

Experimental: HTD1801 500 mg BID - Subjects received 1000 mg/day HTD1801

Experimental: HTD1801 1000 mg BID - Subjects received 2000 mg/day HTD1801

Placebo comparator: Placebo -


Treatment: Drugs: HTD1801 Tablets, 500 mg
500 mg/day (250 mg BID)

Treatment: Drugs: HTD1801 Tablets, 1000 mg
1000 mg/day (500 mg BID)

Treatment: Drugs: HTD1801 Tablets, 2000 mg
2000 mg/day (1000 mg BID)

Treatment: Drugs: Placebo to match 500 mg HTD1801
2 tablets/day (1 tablet BID)

Treatment: Drugs: Placebo to match 1000 mg HTD1801
4 tablets/day (2 tablet BID)

Treatment: Drugs: Placebo to match 2000 mg HTD1801
8 tablets/day (4 tablet BID)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration
Timepoint [1] 0 0
0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Secondary outcome [2] 0 0
Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration
Timepoint [2] 0 0
0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28
Secondary outcome [3] 0 0
Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration
Timepoint [3] 0 0
0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Secondary outcome [4] 0 0
Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration
Timepoint [4] 0 0
0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28
Secondary outcome [5] 0 0
Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration
Timepoint [5] 0 0
0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Secondary outcome [6] 0 0
Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration
Timepoint [6] 0 0
0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28
Secondary outcome [7] 0 0
Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups
Timepoint [7] 0 0
Baseline, Day 14, Day 28
Secondary outcome [8] 0 0
Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups
Timepoint [8] 0 0
Baseline, Day 14, Day 28
Secondary outcome [9] 0 0
Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups
Timepoint [9] 0 0
Baseline, Day 14, Day 28
Secondary outcome [10] 0 0
Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups
Timepoint [10] 0 0
Baseline, Day 14, Day 28

Eligibility
Key inclusion criteria
1. Have given written informed consent
2. Males or females aged 18 to 70 years old at the time of first dosing
3. Have a body mass index (BMI) of >25.0 and = 45.0 kg/m2 at Screening
4. Have a documented history of hypercholesterolemia, defined as LDL-C = 2.59 mmol/L
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The use of any anti-dyslipidemia agent within 28 days prior to dosing
2. History of a total cholesterol = 10.35 mmol/L or triglyceride = 11.3 mmol/L
3. History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
4. Significant peripheral or coronary vascular disease
5. Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure =160/100 mmHg, or = 90/60 mmHg
6. Primary hypothyroidism (thyroid stimulating hormone [TSH] > upper limit or normal [ULN] and free T4 < lower limit of normal [LLN]), primary subclinical hypothyroidism (screening TSH > ULN and free T4 within normal limits [WNL]), or secondary hypothyroidism (screening TSH < LLN and free T4< LLN) at Screening
7. Glucose-6-phosphate dehydrogenase (G6PD) deficiency

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
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
13/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd. - Herston
Recruitment hospital [2] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
HighTide Biopharma Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of HTD1801 in overweight to obese adults with hypercholesterolemia. There were 3 cohorts of dose levels as 500, 1000 and 2000 mg/day, with 16 subjects planned for each cohort randomized 3:1 to receive either HTD1801 or Placebo.
Trial website
https://clinicaltrials.gov/study/NCT03381287
Trial related presentations / publications
Di Bisceglie AM, Watts GF, Lavin P, Yu M, Bai R, Liu L. Pharmacokinetics and pharmacodynamics of HTD1801 (berberine ursodeoxycholate, BUDCA) in patients with hyperlipidemia. Lipids Health Dis. 2020 Nov 12;19(1):239. doi: 10.1186/s12944-020-01406-4.
Public notes

Contacts
Principal investigator
Name 0 0
Adrian Di Bisceglie, MD,FACP,FAASLD
Address 0 0
HighTide Therapeutics USA, LLC
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03381287