A Phase 1, First Time in Humans Study of NST-1024
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
1 other identifier
interventional
96
1 country
1
Brief Summary
A first time in man study of NST-1024
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2020
CompletedFirst Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2022
CompletedDecember 2, 2022
December 1, 2022
1.6 years
November 5, 2020
December 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
incidence and severity of adverse events
4 weeks
Secondary Outcomes (3)
AUC
3-17 days
Cmax
3-17 days
Half life
3-17 days
Study Arms (2)
NST-1024
EXPERIMENTALNST-1024 capsules given once daily for up to 14 days
Placebo
PLACEBO COMPARATORMatching placebo capsules to NST-1024 given once daily for up to 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Leeds Clinical Research Unit
Leeds, West Yorkshire, LS2 9LH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
November 16, 2020
Study Start
October 27, 2020
Primary Completion
June 20, 2022
Study Completion
June 20, 2022
Last Updated
December 2, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share