Parenteral Nutrition Associated Liver Disease, Short Bowel Syndrome
Conditions
Brief 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.
Interventions
DRUGNST 6179
orally administered, fully synthetic medium chain fatty acid (MCFA) analogue
DRUGPlacebo
inactive analogue
Sponsors
NorthSea Therapeutics B.V.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females, of any race, between 18 and 65 years of age, inclusive. 2. Body mass index between 18.0 and 32.0 kg/m\^2, inclusive. 3. 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). 4. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception. 5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions
Exclusion criteria
(additional criteria available): 1. 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). 2. 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). 3. Any of the following: 1. QT interval corrected for heart rate using Fridericia's method (QTcF) \> 450 ms confirmed by repeat measurement. 2. QRS duration \> 110 ms confirmed by repeat measurement. 3. PR interval \> 220 ms confirmed by repeat measurement. 4. findings which would make QTc measurements difficult or QTc data uninterpretable. 5. history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome). 4. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee). 5. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the investigator (or designee). 6. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing. 7. Vegetarians, vegans, and/or unable to consume the high fat breakfast (subjects participating in a food effect evaluation only). 8. History of alcoholism or drug/chemical abuse within 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AEs and SAEs Following Administration of NST 6179 | From screening to 14 days post final dose, up to 4 weeks. | Assessment of number of participants with AEs and SAEs to determine safety profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of NST 6179 | Day 1 | Measure of peak plasma concentration of NST 6179 after dose on Day 1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| NST 6179 Concentrations and QT Interval | From screening to 14 days post final dose, up to 4 weeks. | assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Dose Placebo Participants in Part A randomised to receive a single dose of placebo. | 10 |
| Single Dose 50 mg NST-6179 Participants in Part A randomised to receive a single dose of 50 mg NST-6179. | 6 |
| Single Dose 200 mg NST-6179 Participants in Part A randomised to receive a single dose of 200 mg NST-6179. | 6 |
| Single Dose 400 mg NST-6179 Participants in Part A randomised to receive a single dose of 400 mg NST-6179. | 6 |
| Single Dose 600 mg NST-6179 Participants in Part A randomised to receive a single dose of 600 mg NST-6179. | 6 |
| Single Dose 1000 mg NST-6179 Participants in Part A randomised to receive a single dose of 1000 mg NST-6179. | 6 |
| Multiple Dose Placebo Participants in Part B randomised to receive multiple doses of placebo. | 6 |
| Multiple Dose 200 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD). | 8 |
| Multiple Dose 400 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD). | 8 |
| Multiple Dose 1000 mg NST-6179 (QD) Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD). | 8 |
| Total | 70 |
Baseline characteristics
| Characteristic | Total | Single Dose 50 mg NST-6179 | Single Dose Placebo | Single Dose 200 mg NST-6179 | Single Dose 400 mg NST-6179 | Single Dose 600 mg NST-6179 | Single Dose 1000 mg NST-6179 | Multiple Dose Placebo | Multiple Dose 200 mg NST-6179 (QD) | Multiple Dose 400 mg NST-6179 (QD) | Multiple Dose 1000 mg NST-6179 (QD) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 6 Participants | 10 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 6 Participants | 9 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 7 Participants | 8 Participants | 7 Participants |
| Region of Enrollment United Kingdom | 70 participants | 6 participants | 10 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 29 Participants | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 0 Participants |
| Sex: Female, Male Male | 41 Participants | 3 Participants | 6 Participants | 1 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 4 / 10 | 2 / 6 | 2 / 6 | 2 / 6 | 2 / 6 | 2 / 6 | 2 / 6 | 5 / 8 | 6 / 8 | 5 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Participants With AEs and SAEs Following Administration of NST 6179
Assessment of number of participants with AEs and SAEs to determine safety profile
Time frame: From screening to 14 days post final dose, up to 4 weeks.
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 4 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 0 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 4 Participants |
| Single Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 2 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 0 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 2 Participants |
| Single Dose 50 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 2 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 2 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 0 Participants |
| Single Dose 200 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 2 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 2 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Single Dose 400 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 2 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 2 Participants |
| Single Dose 600 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 0 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 1 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 1 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 1 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 1 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 2 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 0 Participants |
| Single Dose 1000 mg NST-6179 | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 1 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 2 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 2 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 2 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 1 Participants |
| Multiple Dose Placebo | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 2 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 2 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 0 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 2 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 2 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 5 Participants |
| Multiple Dose 200 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 5 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 5 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 4 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 5 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 3 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 3 Participants |
| Multiple Dose 400 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 6 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate TEAEs | 1 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall TEAEs | 5 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Serious TEAEs | 0 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Severe TEAEs | 0 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Overall treatment-related TEAEs | 5 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to death | 0 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild treatment-related TEAEs | 4 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Moderate treatment-related TEAEs | 1 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | TEAEs leading to discontinuation | 0 Participants |
| Multiple Dose 1000 mg NST-6179 (QD) | Number of Participants With AEs and SAEs Following Administration of NST 6179 | Mild TEAEs | 5 Participants |
Secondary
Peak Plasma Concentration (Cmax) of NST 6179
Measure of peak plasma concentration of NST 6179 after dose on Day 1
Time frame: Day 1
Population: PK population (all subjects who received NST-6179)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Single Dose Placebo | Peak Plasma Concentration (Cmax) of NST 6179 | 1100 ng/mL | Geometric Coefficient of Variation 54.7 |
| Single Dose 50 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 4880 ng/mL | Geometric Coefficient of Variation 49.9 |
| Single Dose 200 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 13200 ng/mL | Geometric Coefficient of Variation 29.2 |
| Single Dose 400 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 18300 ng/mL | Geometric Coefficient of Variation 33.7 |
| Single Dose 600 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 27200 ng/mL | Geometric Coefficient of Variation 33.7 |
| Single Dose 1000 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 5690 ng/mL | Geometric Coefficient of Variation 51 |
| Multiple Dose Placebo | Peak Plasma Concentration (Cmax) of NST 6179 | 10500 ng/mL | Geometric Coefficient of Variation 60.4 |
| Multiple Dose 200 mg NST-6179 (QD) | Peak Plasma Concentration (Cmax) of NST 6179 | 29100 ng/mL | Geometric Coefficient of Variation 25.3 |
Secondary
Peak Plasma Concentration (Cmax) of NST 6179
Measure of peak plasma concentration of NST 6179 after dose on Day 14
Time frame: Day 14
Population: PK population (all subjects who received NST-6179)
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Single Dose Placebo | Peak Plasma Concentration (Cmax) of NST 6179 | 6920 ng/mL | Geometric Coefficient of Variation 28 |
| Single Dose 50 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 10000 ng/mL | Geometric Coefficient of Variation 34.9 |
| Single Dose 200 mg NST-6179 | Peak Plasma Concentration (Cmax) of NST 6179 | 31800 ng/mL | Geometric Coefficient of Variation 39.9 |
Other Pre-specified
NST 6179 Concentrations and QT Interval
assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected
Time frame: From screening to 14 days post final dose, up to 4 weeks.