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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NST 6179 | Active Comparator | double blind, single ascending and multiple ascending dose, sequential group design |
|
| Placebo | Placebo Comparator | matched placebo arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NST 6179 | Drug | orally administered, fully synthetic medium chain fatty acid (MCFA) analogue |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From screening to 14 days post final dose, up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of NST 6179 | Measure of peak plasma concentration of NST 6179 after dose on Day 1 | Day 1 |
| Peak Plasma Concentration (Cmax) of NST 6179 | Measure of peak plasma concentration of NST 6179 after dose on Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| NST 6179 Concentrations and QT Interval | assess for correlation of potential cardiotoxicity by looking at PK of NST 6179 and ECG results collected | From screening to 14 days post final dose, up to 4 weeks. |
Inclusion Criteria:
Exclusion Criteria (additional criteria available):
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:
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).
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).
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
Vegetarians, vegans, and/or unable to consume the high fat breakfast (subjects participating in a food effect evaluation only).
History of alcoholism or drug/chemical abuse within 2 years
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Ltd | Leeds | LS2 9LH | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Dose Placebo | Participants in Part A randomised to receive a single dose of placebo. |
| FG001 | Single Dose 50 mg NST-6179 | Participants in Part A randomised to receive a single dose of 50 mg NST-6179. |
| FG002 | Single Dose 200 mg NST-6179 | Participants in Part A randomised to receive a single dose of 200 mg NST-6179. |
| FG003 | Single Dose 400 mg NST-6179 | Participants in Part A randomised to receive a single dose of 400 mg NST-6179. |
| FG004 | Single Dose 600 mg NST-6179 | Participants in Part A randomised to receive a single dose of 600 mg NST-6179. |
| FG005 | Single Dose 1000 mg NST-6179 | Participants in Part A randomised to receive a single dose of 1000 mg NST-6179. |
| FG006 | Multiple Dose Placebo | Participants in Part B randomised to receive multiple doses of placebo. |
| FG007 | Multiple Dose 200 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD). |
| FG008 | Multiple Dose 400 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD). |
| FG009 | Multiple Dose 1000 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Dose Placebo | Participants in Part A randomised to receive a single dose of placebo. |
| BG001 | Single Dose 50 mg NST-6179 | Participants in Part A randomised to receive a single dose of 50 mg NST-6179. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Safety population | Posted | Count of Participants | Participants | From screening to 14 days post final dose, up to 4 weeks. |
|
From screening to 14 days post final dose, up to 4 weeks.
Reporting through regular investigator assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Dose Placebo | Participants in Part A randomised to receive a single dose of placebo. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Yokley | NorthSea Therapeutics BV | 31 035760 65 05 | info@northseatherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2022 | Mar 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2022 | Mar 28, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo |
| Drug |
inactive analogue |
|
| Day 14 |
| BG002 | Single Dose 200 mg NST-6179 | Participants in Part A randomised to receive a single dose of 200 mg NST-6179. |
| BG003 | Single Dose 400 mg NST-6179 | Participants in Part A randomised to receive a single dose of 400 mg NST-6179. |
| BG004 | Single Dose 600 mg NST-6179 | Participants in Part A randomised to receive a single dose of 600 mg NST-6179. |
| BG005 | Single Dose 1000 mg NST-6179 | Participants in Part A randomised to receive a single dose of 1000 mg NST-6179. |
| BG006 | Multiple Dose Placebo | Participants in Part B randomised to receive multiple doses of placebo. |
| BG007 | Multiple Dose 200 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD). |
| BG008 | Multiple Dose 400 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD). |
| BG009 | Multiple Dose 1000 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD). |
| BG010 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Single Dose 200 mg NST-6179 |
Participants in Part A randomised to receive a single dose of 200 mg NST-6179. |
| OG003 | Single Dose 400 mg NST-6179 | Participants in Part A randomised to receive a single dose of 400 mg NST-6179. |
| OG004 | Single Dose 600 mg NST-6179 | Participants in Part A randomised to receive a single dose of 600 mg NST-6179. |
| OG005 | Single Dose 1000 mg NST-6179 | Participants in Part A randomised to receive a single dose of 1000 mg NST-6179. |
| OG006 | Multiple Dose Placebo | Participants in Part B randomised to receive multiple doses of placebo. |
| OG007 | Multiple Dose 200 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD). |
| OG008 | Multiple Dose 400 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD). |
| OG009 | Multiple Dose 1000 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD). |
|
|
| Secondary | Peak Plasma Concentration (Cmax) of NST 6179 | Measure of peak plasma concentration of NST 6179 after dose on Day 1 | PK population (all subjects who received NST-6179) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 |
|
|
|
| Secondary | Peak Plasma Concentration (Cmax) of NST 6179 | Measure of peak plasma concentration of NST 6179 after dose on Day 14 | PK population (all subjects who received NST-6179) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 14 |
|
|
|
| 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 | Not Posted | From screening to 14 days post final dose, up to 4 weeks. | Participants |
| 0 |
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | Single Dose 50 mg NST-6179 | Participants in Part A randomised to receive a single dose of 50 mg NST-6179. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Single Dose 200 mg NST-6179 | Participants in Part A randomised to receive a single dose of 200 mg NST-6179. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | Single Dose 400 mg NST-6179 | Participants in Part A randomised to receive a single dose of 400 mg NST-6179. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Single Dose 600 mg NST-6179 | Participants in Part A randomised to receive a single dose of 600 mg NST-6179. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | Single Dose 1000 mg NST-6179 | Participants in Part A randomised to receive a single dose of 1000 mg NST-6179. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | Multiple Dose Placebo | Participants in Part B randomised to receive multiple doses of placebo. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG007 | Multiple Dose 200 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 200 mg NST-6179 (QD). | 0 | 8 | 0 | 8 | 5 | 8 |
| EG008 | Multiple Dose 400 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 400 mg NST-6179 (QD). | 0 | 8 | 0 | 8 | 6 | 8 |
| EG009 | Multiple Dose 1000 mg NST-6179 (QD) | Participants in Part B randomised to receive multiple doses of 1000 mg NST-6179 (QD). | 0 | 8 | 0 | 8 | 5 | 8 |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Medical device site irritation | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Feeling of body temperature change | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Vaulvovaginal candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Micturition frequency decreased | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |