Asthma MedDRA version: 17.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: FX125L
Product Code: FX125L
Pharmaceutical Form: Capsule
INN or Proposed INN: N/A
Current Sponsor code: FX125L
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
STX Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give written informed consent and to comply with the requirements of the study. 2. Male or female aged 18–77 years, inclusive. 3. Body mass index 18–35 kg/m2, inclusive. 4. Females of child-bearing potential must be using an adequate and medically acceptable contraception method as outlined in the protocol. 5. Females of child-bearing potential must not be lactating or pregnant (negative serum beta-human chorionic gonadotropin on Screening or urine pregnancy test at Day -1 visit). 6. Male patients must agree not to donate sperm, and to take appropriate precautions to avoid fathering a child, throughout the study and until 90 days after the end of treatment. 7. Documented medical history of asthma at least 3 months prior to Screening, or equivalent that confirms the diagnosis meets this criteria. 8. Forced expiratory volume in 1 second (FEV1) =90% of predicted at Screening and =92% of predicted on (Day -1). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Any condition, including findings in the medical history or in the pre-study assessments, which, in the opinion of the Investigator, constitute a risk or contraindication for the participation of the subject in the study, or that could interfere with the study objectives, conduct, or evaluation including, but not limited to: i. Any clinically significant abnormality in the results of screening safety laboratory tests. ii. Positive test for drugs of abuse at screening or Day -1. iii. Positive alcohol breath test at screening or Day -1. iv. Positive results from serum tests for hepatitis B surface antigen (HbAg) (except if due to vaccination), hepatitis C (HCV), or human immunodeficiency virus (HIV). v. History or presence of liver disease. vi. History or presence of endocrine disorders or diseases affecting the hypothalamic-pituitary-adrenal axis, including acromegaly, growth hormone deficiency, adrenal insufficiency, Cushing’s syndrome, Grave’s Disease, Hashimoto’s Disease, uncontrolled diabetes mellitus, with the exception of idiopathic hypothyroidism in patients over the age of 60 years. vii. History of hypofertility (males only) viii. History of cancer in the preceding 5 years (except adequately treated basal cell carcinoma of the skin and squamous cell carcinoma in situ of the skin) 2. History or presence of drug or alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. 3. History of active manifestation of a serious psychiatric illness that in the opinion of the PI would deem a subject to be unsuitable for inclusion in the study including acute depression, suicidal ideation or psychosis. 4. Positive test for latent tuberculosis. 5. Requirement for immunisations or vaccinations within 7 days of any visit during the entire study period (including the screening, treatment and follow-up phases). 6. Previous participation in the current study, or administration of any investigational product within 12 weeks (or at least 5 times the half-life of the product, if longer) prior to entry into the study. 7. Acute infection requiring a visit to a doctor or hospital, or treatment with a prescription-only medication, within 2 weeks prior to Day 1. 8. Any condition that may affect the absorption of an orally administered drug, for example, but not limited to, ulcerative colitis or resection of the stomach or small bowel. 9. Required to take a proscribed drug (as defined in the protocol) during the study. 10. History of treatment with corticosteroids within 1 month of screening, including inhaled steroids (with the exception of topical steroid creams containing 2% or less hydrocortisone). 11. History of treatment with a biological anti-inflammatory therapy within 6 months of screening. 12. History of exposure to FX125L. 13. Received treatment with inhaled or oral asthma or allergy medications except ß-agonists (e.g., corticosteroids, anti-histamines, leukotriene receptor antagonists, methylxanthines) within 4 weeks prior to Screening 14. Suffer from respiratory diseases, other than asthma or allergic rhinitis, which would interfere with asthma disease assessments. 15. Respiratory infections within 8 weeks prior to Day 1. 16. Asthma exacerbation leading to hospitalisation for more than 2 days within the last 6 months or a hospital accident and emergency visit due to asthma exacerbation in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect of FX125L on forced expiratory volume in one second (FEV1) following oral delivery of FX125L for 8 weeks.;Timepoint(s) of evaluation of this end point: Forced expiratory volume in one second (FEV1): Screening, Day -1, Day 1, Day 10, Day 42, Day 56 and Day 84 (optional). ;Primary end point(s): Change in mean forced expiratory volume in one second (FEV1) from both pre-treatment visits (Screening and Day -1) compared to the mean from Day 10, Day 42 and Day 56 visits.;Secondary Objective: • To determine the safety of once daily oral dosing with FX125L 600 mg for up to 8 weeks in patients with asthma • To estimate the effect of FX125L on additional markers of asthma symptoms and disease activity: Asthma Control Days and frequency of inhaled ß-agonist rescue medication; Asthma Control Test score; Patient and Physician Global Assessment using a Visual Analog Scale; and sputum eosinophilia following oral delivery of FX125L for 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Full differential leukocyte count in blood • Full differential leukocyte count in sputum plugs • Asthma Control Days and frequency of inhaled ß-agonist rescue medication throughout the study • Asthma Control Test score • Patient and Physician Global Assessment using a Visual Analog Scale Safety • Physical examination, vital signs, 12-lead Electrocardiogram (ECG), clinical laboratory assessments • Adverse events (AEs) throughout the study Endocrine Markers of endocrine function, including Total IGF-1, free T4, free T3, ACTH, TSH and FSH. ;Timepoint(s) of evaluation of this end point: • Full differential leukocyte count (blood): Screening, Day (D) -1, 10, 42, 56, & 84 & optionally at other time points • Full differential leukocyte count (sputum): Screening, D-1, 42 & 56 & optionally at D84 • Asthma Control Days & freq of inhaled ß-agonist rescue medication: Screening, D1, 10, 42 & 56 • Asthma Control Test score: Screening, D -1, 42 & 56 & optionally at D84 • Patient & Physician Global Assessment: Screening, D-1, 10, 42 & 56 & optionally at D84 Safety • Physical examination, vital signs, 12-lead ECGs, clinical lab assessments: Screening, Day -1 (excl vitals & ECG), Day 1 (vitals & ECG only), Day 10, 42, 56 & 84 • Adverse Events throughout the study Endocrine Markers of endocrine function: Screening, Day 10, 56 & 84 Total IGF-1: Screening, Day -1, 42 & 56 | — |
Countries
United Kingdom
Contacts
Public ContactChief Operating Officer
STX Pharma
Outcome results
None listed