A study to investigate the effect of NOC-100 in terms of efficacy, safety, tolerability and drug levels in the blood in patients with acute and chronic cough.
- Conditions
- CoughMedDRA version: 20.0Level: PTClassification code 10011224Term: CoughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-004715-27-DE
- Lead Sponsor
- ocion Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
Part 1:
1. Male and female participants between the ages of 18 to 80 years, inclusive.
2. Has had CC for = 12 months and a diagnosis of refractory or unexplained CC (Per CHEST chronic cough diagnosis guidelines, Irwin et al, 2018).
3. Chest radiograph or CT thorax within the timeframe supporting the diagnosis of CC, and within the last 60 months, not demonstrating any abnormality considered to be significantly contributing to the CC.
4. If a female of childbearing potential, must be either sexually inactive (abstinent as a lifestyle*) for 28 days prior to the first dosing and throughout the study or using one of the following highly effective birth control methods:
a. hormonal oral contraceptives, transdermal patch, or hormone-releasing intrauterine device for at least 3 months prior to the first dosing and with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of screening and throughout the study.
b. Depot/implantable hormone (e.g., Depo Provera®, Implanon®) for at least 3 months prior to the first dosing and throughout the study.
In addition, female participants of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 14 days after the last dose of study drug. Females will also be advised not to donate ova during the trial for at least 30 days after the last dose.
*abstinence should only be used as a contraceptive method if it is in line with the participants’ usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception.
5. If a female of non-childbearing potential, must have undergone one of the following sterilisation procedures at least 6 months prior to the first dosing:
a. hysteroscopic sterilisation;
b. bilateral salpingectomy;
c. hysterectomy;
d. bilateral oophorectomy or
e. or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status.
6. A non-vasectomised, male participant must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing. (No restrictions are required for a vasectomised male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomised less than 4 months prior to the first dosing must follow the same restrictions as a non-vasectomised male).
7. If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
8.Understands the study procedures in the Informed Consent Form (ICF) and be willing and able to comply with the protocol. Participants must have signed and dated an IRB/IEC approved written ICF including all authorisations required by local law (e.g., collection and handling of personal data, especially health information). The ICF must be obtained before the performance of any protocol related procedures that are not part of the normal standard of care.
9. Aspartate transaminase (AST) and alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase (ALP) and bilirubin =1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
10. Creatinine clearance =50 mL/min.
11. Awake-cough frequency of =10 per hour (average) at Screening.
12. Score of =40
Part 1:
1. Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with >20 pack-year smoking history.
2. Current diagnosis of COPD, bronchiectasis, unexplained pulmonary fibrosis, or asthma.
3. History of concurrent malignancy or recurrence of malignancy in the 2 years prior to the screening visit, participants with adequately treated non-melanomatous skin carcinoma will be permitted.
4. History of recent respiratory tract infection (including SARS-CoV-2 infection) or recent significant change in pulmonary status within 4 weeks of the screening visit.
5. Is currently or has at any time had severe symptoms related to SARS-CoV-2 and required hospitalisation.
6. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
7. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
8. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
9. History of recent (within the past 6 months) acute myocardial infarction, acute thromboembolic event, myocarditis, hospitalization for unstable angina or heart failure; history or presence of a clinically important arrhythmia; Wolff-Parkinson-White syndrome or bundle branch block.
10. History or presence of alcohol or drug use disorder, per DSM-5, within the past 2 years prior to screening.
11. History or presence of hypersensitivity to the study drugs or related compounds.
12. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
13. Current opiate/opioid use in the past 7 days prior to screening, or medical history of opiate/opioid use disorder (OUD).
14. Unable to refrain from the use of:
a. Gabapentin, pregabalin, and/or amitryptline or other tricyclics within 4 weeks prior to screening and throughout the study.
b. Chronic, systemic corticosteroid use within 4 weeks prior to screening and throughout the study.
c. Inhalers including long-acting and short acting beta 2 agonists (LABA, SABA) and ICS within 12 weeks prior to screening and throughout the study.
d. Lidocaine or related compounds of any form within 14 days prior to screening and throughout the study.
e. Medication or remedies to aid sleeping 14 days prior to screening and throughout the study.
f. ACE-inhibitor within 12 weeks prior to screening and throughout the study.
g. Antitussives 7 days prior to screening and throughout the study.
h. Speech and language therapy for CC within 4 weeks prior to screening and throughout the study.
i. Food and beverages containing xanthines/caffeine for 12 hours prior to screening (small amounts of caffeine derived from normal foodstuffs e.g., 250 mL/8 oz./1 cup decaffeinated coffee or other decaffeinated beverage, per day, with the exception of espresso; 45 g/1.5 oz. chocolate bar, per day, would not be considered a deviation to this restriction).
j. Food and beverages containing alcohol for 24 h prior to screening.
15. Donation of blood or plasma within 90 days prior to the first dosing.
16. Participation in another clinical study involving an investigational drug within 60 days prior to the first dosing. The 60-day window will b
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method