CompletedPhase 1

Study of NST-6179 in Healthy Subjects

United Kingdom70 participantsStarted 2021-11-11

Plain-language summary

A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess safety and tolerability of single and multiple doses of NST-6179 in healthy male and female subjects.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Males or females, of any race, between 18 and 65 years of age, inclusive.
✓. Body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
✓. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and/or check in as assessed by the investigator (or designee).
✓. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
✓. Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Exclusion criteria

✕. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
✕. 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).
✕. Any of the following:
✕. QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 ms confirmed by repeat measurement.
✕. QRS duration \> 110 ms confirmed by repeat measurement.
✕. PR interval \> 220 ms confirmed by repeat measurement.
✕. findings which would make QTc measurements difficult or QTc data uninterpretable.
✕. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).

What they're measuring

Number of Participants With AEs and SAEs Following Administration of NST 6179

Timeframe: From screening to 14 days post final dose, up to 4 weeks.

Trial details

NCT IDNCT05181085

SponsorNorthSea Therapeutics B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-27

Results submitted2023-03-28

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