A clinical trial of MK-1654 in healthy volunteers.
- Conditions
- Respiratory Syncytial Virus InfectionMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-003347-28-GB
- Lead Sponsor
- Merck Sharp & Dohme Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 90
1. In good health with no history of major medical conditions that will interfere with subject safety, as defined by medical history, physical examination (including vital signs), ECG, and routine laboratory tests and determined by the Investigator at a screening evaluation.
2. Participants will have a documented medical history either prior to entering the study and/or following medical history review with the study physician at screening.
Demographics
3. Participant is male or female.
4. Participant is from 18 years to 55 years of age inclusive, at the time of signing the study specific informed consent.
5. A total body weight = 50 kg and Body Mass Index (BMI) = 18 kg/m2 and = 30kg/m2.
Male Participants
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. Male participants must agree to the contraceptive requirements below at dosing and continuing until 90 days after dosing/28 days after viral inoculation – whichever is later.
• Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male and female) to the IMP.
• Male sterilisation with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure). This applies only to males participating in the study.
• In addition, for female partners of child bearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned below for female participants.
• True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
In addition to the contraceptive requirements above, male participants must agree not to donate sperm until 90 days after the date of dosing.
Female Participants
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
7. Female participants of childbearing potential must have a negative pregnancy test at screening and prior to dosing.
Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to dosing. The contraception use must continue until 30 days after dosing/28 days after the date of viral inoculation - whichever is later. Highly effective contraception is as described below:
• Established (a minimum of 2 weeks prior to dosing) use of hormonal methods of contraception described below.
1. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
1) oral
2) intravaginal
3) transdermal
2. progestogen-only hormonal contraception associated with inhibition of ovulation:
1) oral
2) injectable
3) implantable
Note: when hormonal methods of contraception are used, male partners are required to use a condom with a spermicide.
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• Bilateral tubal ligation
• Male sterilisation (with the appropriate written docum
Medical Conditions
1. Females who: Are breastfeeding or have been pregnant within 6 months prior to the study enrollment.
2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunesuppression), metabolic, urological, renal, neurological, or psychiatric disease (including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities, for example psychosis; participants with a history of depression of any severity within the last 2 years prior to IMP dosing should only be included if the PHQ-9 score is less than or equal to 4). The following conditions apply:
• Participants with clinically mild atopic eczema/atopic dermatitis and clinically mild psoriasis may be included at the Investigator's discretion (e.g., if small amounts of regular topical steroids are used, no eczema in cubital fossa; moderate to large amounts of daily dermal corticosteroids is an exclusion).
• Rhinitis (including hay fever) which is clinically active or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of IMP dosing. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI’s discretion.
• Participants with a physician diagnosed underactive thyroid who have been controlled on treatment for at least 6 months with evidence of a normal thyroid function test (TFT) can be included at the discretion of the PI.
• Any concurrent serious illness including history of malignancy that may interfere with the aims of the study or a subject completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
• Participants reporting physician diagnosed migraine can be included as long as there are not associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion.
• Participants with physician diagnosed mild Irritable Bowel Syndrome (IBS) not requiring regular treatment can be included at the discretion of the PI.
3. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral inoculation, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
4. Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months prior to IMP dosing and/or history of being hospitalized due to epistaxis on any previous occasion.
5. History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to IMP dosing.
6. And/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study and necessary investigations.
7. History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
8. Confirmed positive test for drugs of abuse prior to randomization.
9.
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