A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled, Multicenter, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of HTD1801 in Adults With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381287
• Other study ID #: HTD1801.PCT004
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 13, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2022
• Source: HighTide Biopharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• HTD1801 Tablets, 500 mg
500 mg/day (250 mg BID)
• HTD1801 Tablets, 1000 mg
1000 mg/day (500 mg BID)
• HTD1801 Tablets, 2000 mg
2000 mg/day (1000 mg BID)
• Placebo to match 500 mg HTD1801
2 tablets/day (1 tablet BID)
• Placebo to match 1000 mg HTD1801
4 tablets/day (2 tablet BID)
• Placebo to match 2000 mg HTD1801
8 tablets/day (4 tablet BID)

Locations

Country	Name	City	State
Australia	CMAX Clinical Research Pty Ltd	Adelaide	South Australia
Australia	Q-Pharm Pty Ltd.	Herston	Queensland
Australia	Linear Clinical Research	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
HighTide Biopharma Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)	TEAEs are defined as any AEs that commenced on or after exposure to study drug or any pre-existing AE that worsened in either intensity or frequency after exposure to study drug.	4 weeks
Secondary	Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Secondary	Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28
Secondary	Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Secondary	Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28
Secondary	Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration		0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1
Secondary	Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration		0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28
Secondary	Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups		Baseline, Day 14, Day 28
Secondary	Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups		Baseline, Day 14, Day 28
Secondary	Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups		Baseline, Day 14, Day 28
Secondary	Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups		Baseline, Day 14, Day 28