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A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT03381287
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd

Brief Summary:
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, PK, and PD profiles of HTD1801 in overweight to obese adults with hypercholesterolemia. There will be 3 cohorts of dose levels as 500, 1000 and 2000mg/day, 16 subjects for each cohort with 12 subjects will administer HTD1801 and 4 subjects will administer Placebo.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: HTD1801 Tablets, 500mg Drug: HTD1801 Tablets, 1000mg Drug: HTD1801 Tablets, 2000mg Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 500mg HTD1801 Drug: HTD1801 Tablets, 500mg
16 participants will be randomized 3:1 to receive 500mg of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.

Experimental: 1000mg HTD1801 Drug: HTD1801 Tablets, 1000mg
16 participants will be randomized 3:1 to receive 1000mg tablets of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.

Experimental: 2000mg HTD1801 Drug: HTD1801 Tablets, 2000mg
16 participants will be randomized 3:1 to receive 2000mg of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.




Primary Outcome Measures :
  1. frequency and severity of adverse events [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Maximum plasma concentration of HTD1801 components (Cmax) [ Time Frame: 4 weeks ]
  2. Time to Cmax (Tmax) [ Time Frame: 4 weeks ]
  3. change of Low-density lipoprotein-C (LDL-C) [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381287


Contacts
Contact: S Gamble, Ph. D. +1 301-801-8815 clinical.trials@hightidebio.com

Locations
Australia, Queensland
Q-Pharm Pty Ltd. Recruiting
Herston, Queensland, Australia, 4006
Contact: Maggie Fung    + 61 (0)738453657    m.fung@qpharm.com.au   
Contact: Linda Dunn    + 61 (0)738453629    l.dunn@qpharm.com.au   
Principal Investigator: Paul Griffin, BSc, MBBS         
Australia, South Australia
CMAX Clinical Research Pty Ltd Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Katherine Mudge    +61 (0)870887949    katherine.mudge@cmax.com.au   
Contact: Nicole Ong    +61 (0)870887945    nicole.ong@cmax.com.au   
Principal Investigator: Nicholas Farinola, BSc, BMBS         
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Shashi Aggarwal    +61 (0)863825100    saggarwal@linear.org.au   
Contact: Jennifer Hu    +61 (0)863825123    jhu@linear.org.au   
Principal Investigator: Gerald Watts, DSc, PhD, DM         
Sponsors and Collaborators
HighTide Biopharma Pty Ltd

Responsible Party: HighTide Biopharma Pty Ltd
ClinicalTrials.gov Identifier: NCT03381287     History of Changes
Other Study ID Numbers: HTD1801.PCT004
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases