Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT05084651
Eligibility Criteria:
Key Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study.
* Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive, at Screening.
* In good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory tests at Screening.
* Must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 29.9 kg/m2 inclusive, at Screening.
Key Exclusion Criteria:
* Use of other investigational drugs within 5 half-lives or 30 days prior to first dosing of study treatment, whichever is longer.
* Known family history or known presence of long QT syndrome.
* Known history or current clinically significant arrhythmias.
* History or presence of malignancy of any organ system (other than treated localized basal cell or squamous cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within 5 years of Screening, regardless of whether there is evidence of local recurrence or metastases.
* History or presence of duodenal ulcer, ulcerative colitis, or Crohn's disease.
* Presence of active or uncontrolled thyroid disease.
* Has had cholecystectomy (gallbladder removed).
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05084651
Study Brief:
Protocol Section:
NCT05084651