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Trial record 61 of 92 for:    Primary Sclerosing Cholangitis

A Study of HTD1801 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099603
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd

Brief Summary:
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: HTD1801 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : July 11, 2017
Actual Study Completion Date : October 3, 2017


Arm Intervention/treatment
Placebo Comparator: 0.5g
single dose of placebo to 2 healthy subjects or 0.5g HTD1801 to 6 healthy subjects
Drug: HTD1801
A small molecular compound for the treatment of primary sclerosing cholangitis

Placebo Comparator: 1.0g
single dose of placebo to 2 healthy subjects or 1.0g HTD1801 to 6 healthy subjects
Drug: HTD1801
A small molecular compound for the treatment of primary sclerosing cholangitis

Placebo Comparator: 2.0g
single dose of placebo to 2 healthy subjects or 2.0g HTD1801 to 6 healthy subjects
Drug: HTD1801
A small molecular compound for the treatment of primary sclerosing cholangitis

Placebo Comparator: 4.0g
single dose of placebo to 2 healthy subjects or 4.0g HTD1801 to 6 healthy subjects
Drug: HTD1801
A small molecular compound for the treatment of primary sclerosing cholangitis




Primary Outcome Measures :
  1. Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose [ Time Frame: up to Day 30 ]
    Incidence, severity and causality of AEs and SAEs


Secondary Outcome Measures :
  1. HTD1801 plasma concentration levels after single dose [ Time Frame: 96 hours ]
    Concentration-Time data

  2. Pharmacokinetics (PK) of HTD1801 in plasma after single dose - peak plasma concentration (Cmax) [ Time Frame: 96 hours ]
    PK parameters: Cmax

  3. PK of HTD1801 in plasma after single dose - area under the plasma concentration vs. time curve (AUC) [ Time Frame: 96 hours ]
    PK parameters: AUC

  4. PK of HTD1801 in plasma after single dose - time to peak plasma concentration (Tmax) [ Time Frame: 96 hours ]
    PK parameters: Tmax

  5. PK of HTD1801 in plasma after single dose - half life (T1/2) [ Time Frame: 96 hours ]
    PK parameters: T1/2



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥18 to ≤ 50 years
  2. Body mass index (BMI) ≥18.0 to ≤ 30.0 kg/m2
  3. Current non-user of any nicotine containing products (>6 months)
  4. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for ≥12 months. The site will try to retrieve medical records to document the sterility, however, the absence of records will not exclude screening the participant. If medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Postmenopausal status will be confirmed through testing of FSH levels ≥ 40 IU/mL at screening for amenorrheic female participants <50 years of age.

    Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent or if engaged in sexual relations with a child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from Screening and for a period of 60 days after the last dose of Study Drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that includes: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device). The Principal Investigator will assess the adequacy of methods of contraception on a case-by-case basis.

  5. Ability to provide written informed consent.

Exclusion Criteria:

  1. Participation in an investigational drug study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
  2. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. [Use of ≤2 g per day of paracetamol (acetaminophen) is allowed prior to and during the study at Investigator discretion. The reason for use must be listed either in the subject's baseline information or as an adverse event.]
  3. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
  4. History of any serious adverse reaction or hypersensitivity to any of the product components.
  5. Use of parenterally administered proteins or antibodies within 12 weeks of screening. (Note: Influenza vaccine will be allowed)
  6. Glucose-6-phosphate dehydrogenase(G6PD) deficiency.
  7. History of weight loss > 5% in the 8 weeks prior to screening.
  8. History of any active infection, other than mild viral illness, within 30 days prior to dosing.
  9. History of alcohol or illicit drug abuse as judged by the Investigator within approximately 1 year
  10. Use of any nicotine-containing product within 6 months prior to Screening or at any time during the study and follow-up as confirmed by urine cotinine screening.
  11. Presence of clinically significant medical history, physical, laboratory, or ECG findings that, in the opinion of the Investigator, may potentially compromise the safety of the subject, or interfere with any aspect of study conduct or interpretation of results.

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): NCT03099603


Locations
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Australia, Victoria
Nucleus Network Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
HighTide Biopharma Pty Ltd
Investigators
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Principal Investigator: Janet Wong, Doctor Nucleus Network Ltd

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Responsible Party: HighTide Biopharma Pty Ltd
ClinicalTrials.gov Identifier: NCT03099603     History of Changes
Other Study ID Numbers: 1801.PCT002
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not provided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases