Back to resultsA Phase 1, First Time in Humans Study of NST-1024
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NST-1024
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia
Eligibility Criteria
Inclusion Criteria:
- BMI 18-32 kg/m2
- In good health
- Females will not be pregnant or lactating. Females of childbearing potential must agree to use contraception
- Male subjects must agree to use contraception and refrain from donation of sperm
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- Subjects must have TG levels > 150 mg/dL at screening (Part B only).
Exclusion Criteria:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, CV, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Aspartate aminotransferase, ALT, GGT, ALP, or total bilirubin > 1.2 × ULN at Screening or (first) Check-in, confirmed by 1 repeat if necessary
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (whichever is longer) prior to dosing.
- Use of tobacco- or nicotine-containing products within 1 month prior to Screening, or positive cotinine test at Screening or Check-in.
Sites / Locations
- Covance Leeds Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NST-1024
Placebo
Arm Description
NST-1024 capsules given once daily for up to 14 days
Matching placebo capsules to NST-1024 given once daily for up to 14 days
Outcomes
Primary Outcome Measures
Safety and tolerability
incidence and severity of adverse events
Secondary Outcome Measures
AUC
Area under the PK curve
Cmax
Maximum plasma concentration
Half life
time to reduction in plasma levels by 50%
Full Information
NCT ID
NCT04630366
First Posted
November 5, 2020
Last Updated
December 1, 2022
Sponsor
NorthSea Therapeutics B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04630366
Brief Title
A Phase 1, First Time in Humans Study of NST-1024
Official Title
A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects With Elevated Triglycerides
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NorthSea Therapeutics B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A first time in man study of NST-1024
Detailed Description
A Phase 1, First Time in Man Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NST-1024 in Healthy Subjects and Otherwise Healthy Subjects with Elevated Triglycerides. This will be a double-blind, randomised, placebo-controlled, single and multiple oral dose study conducted in 2 parts. In part A up to 6 cohorts of 8 healthy volunteers will receive single ascending doses of NST-1024 or matching placebo. I part B up to 4 cohorts of 10 otherwise healthy volunteers, with elevated triglycerides will receive daily multiple ascending doses of NST-1024 for 14 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NST-1024
Arm Type
Experimental
Arm Description
NST-1024 capsules given once daily for up to 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules to NST-1024 given once daily for up to 14 days
Intervention Type
Drug
Intervention Name(s)
NST-1024
Intervention Description
NST-1024
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to NST-1024
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
incidence and severity of adverse events
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
AUC
Description
Area under the PK curve
Time Frame
3-17 days
Title
Cmax
Description
Maximum plasma concentration
Time Frame
3-17 days
Title
Half life
Description
time to reduction in plasma levels by 50%
Time Frame
3-17 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 18-32 kg/m2
In good health
Females will not be pregnant or lactating. Females of childbearing potential must agree to use contraception
Male subjects must agree to use contraception and refrain from donation of sperm
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Subjects must have TG levels > 150 mg/dL at screening (Part B only).
Exclusion Criteria:
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, CV, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Aspartate aminotransferase, ALT, GGT, ALP, or total bilirubin > 1.2 × ULN at Screening or (first) Check-in, confirmed by 1 repeat if necessary
History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days or 5 half-lives (whichever is longer) prior to dosing.
Use of tobacco- or nicotine-containing products within 1 month prior to Screening, or positive cotinine test at Screening or Check-in.
Facility Information:
Facility Name
Covance Leeds Clinical Research Unit
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9LH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 1, First Time in Humans Study of NST-1024
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