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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT07266805
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent
* Male or female (sex at birth) aged ≥18 years
* Diagnosis of AAE-C1INH
* History of AAE-C1INH attacks prior to the Screening Visit:
* Participants enrolling in Part 1 must have stable underlying disease of AAE-C1INH
* The underlying condition can reasonably be expected to remain stable for the duration
* Reliable access and ability to use available therapy to effectively manage AAE- C1INH attacks.
* Female participants of childbearing potential must agree to the protocol-specified pregnancy testing and to be abstinent from heterosexual intercourse or to use an acceptable contraception method.
Females of non-childbearing potential (prepubertal, surgically sterile, or postmenopausal with ≥ 12 months amenorrhea and postmenopausal FSH confirmation) are not required to use contraception during the study.
• Capable of recording, without assistance, eDiary and ePRO data using an electronic device, as evidenced by the eDiary and ePRO training.
Exclusion Criteria:
* Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at the Screening Visit (whichever is longer).
* Participants who have previously received prophylactic therapy but have stopped can participate in this study provided the last dose of the treatment was received prior to the timepoint before the Screening Visit
* Any females who are pregnant, plan to become pregnant, or are currently breast-feeding
* Abnormal hepatic function
* Moderate or severe renal impairment
* Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
* History of epilepsy and/or other significant neurological diseases
* Any clinically significant and uncontrolled gastrointestinal dysfunction that may impact study drug absorption
* Evidence of current alcohol or drug abuse
* Use of medications that are moderate and strong inhibitors of cytochrome P450 (CYP) 3A4, or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) at the time of the Screening Visit
* Known hypersensitivity to deucrictibant or any of the excipients of the study drug
* Use of angiotensin-converting enzyme inhibitors or any estrogen-containing medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07266805
Study Brief:
Protocol Section:
NCT07266805