Skip to main content
OpenTrials
Completed

NCT Number: NCT03381287

A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Q-Pharm Pty Ltd., Herston, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have given written informed consent
  • Males or females aged 18 to 70 years old at the time of first dosing
  • Have a body mass index (BMI) of >25.0 and ≤ 45.0 kg/m2 at Screening
  • Have a documented history of hypercholesterolemia, defined as LDL-C ≥ 2.59 mmol/L

Exclusion criteria

  • The use of any anti-dyslipidemia agent within 28 days prior to dosing
  • History of a total cholesterol ≥ 10.35 mmol/L or triglyceride ≥ 11.3 mmol/L
  • History of a clinically significant cardiac arrhythmia or clinically significant abnormal ECG results at Screening
  • Significant peripheral or coronary vascular disease
  • Clinically significant abnormal blood pressure at Screening or Baseline, defined as supine blood pressure ≥160/100 mmHg, or ≤ 90/60 mmHg
  • 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
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Treatment and study plan

HTD1801 Tablets, 500 mg

Drug

500 mg/day (250 mg BID)

HTD1801 Tablets, 1000 mg

Drug

1000 mg/day (500 mg BID)

HTD1801 Tablets, 2000 mg

Drug

2000 mg/day (1000 mg BID)

Placebo to match 500 mg HTD1801

Drug

2 tablets/day (1 tablet BID)

Placebo to match 1000 mg HTD1801

Drug

4 tablets/day (2 tablet BID)

Placebo to match 2000 mg HTD1801

Drug

8 tablets/day (4 tablet BID)

Primary outcomes

  1. Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of HTD1801 Components After Single-dose Oral Administration

    Time frame: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

  2. Maximum Plasma Concentration (Cmax) of HTD1801 Components After Multiple-dose Oral Administration

    Time frame: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

  3. Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Single-dose Oral Administration

    Time frame: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

  4. Time to Maximum Plasma Concentration (Tmax) of HTD1801 Components After Multiple-dose Oral Administration

    Time frame: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

  5. Plasma Half-life of HTD1801 Components (T1/2) After Single-dose Oral Administration

    Time frame: 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 1

  6. Plasma Half-life of HTD1801 Components (T1/2) After Multiple-dose Oral Administration

    Time frame: 0. 0.25, 0.5, 1, 2, 3, 4, 8, 12 and 24 hours on Day 28

  7. Percent Change in Low-density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 28 Within and Between Treatment Groups

    Time frame: Baseline, Day 14, Day 28

  8. Percent Change in Triglycerides From Baseline to Day 28 Within and Between Treatment Groups

    Time frame: Baseline, Day 14, Day 28

  9. Percent Change in Free-fatty Acids (FFA) From Baseline to Day 28 Within and Between Treatment Groups

    Time frame: Baseline, Day 14, Day 28

  10. Percent Change in Lipoprotein-A From Baseline to Day 28 Within and Between Treatment Groups

    Time frame: Baseline, Day 14, Day 28

Sponsors and collaborators

Lead sponsor

HighTide Biopharma Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.