A study to investigate what effects FX125L (taken by mouth) has on adults with mild to moderate asthma

• Conditions: Asthma; MedDRA version: 17.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-002052-84-GB
• Lead Sponsor: STX Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-18
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified