CTX001 With and Without IronCTX001 With IronCTX001 Multiple DosePlacebo With and Without IronPlacebo With IronPlacebo Multiple Dose
CTX001 With and Without Iron: There are two treatment periods. In the first, CTX001 is administered as a single dose (tablet) by itself. In the second, CTX001 is administered as a single dose (tablet) with iron.
CTX001 With Iron: There are two treatment periods. In one, CTX001 is administered as a single dose (tablet) with iron (tablet) following a high fat, high calorie meal. In the other, CTX001 is administered as a single dose (tablet) with iron (tablet) under fasting conditions.
CTX001 Multiple Dose: CTX001 (tablet) is administered daily for 7 consecutive days.
Placebo With and Without Iron: There are two treatment periods. In the first, placebo is administered as a single dose (tablet) by itself. In the second, placebo is administered as a single dose (tablet) with iron.
Placebo With Iron: There are two treatment periods. In one, placebo is administered as a single dose (tablet) with iron (tablet) following a high fat, high calorie meal. In the other, placebo is administered as a single dose (tablet) with iron (tablet) under fasting conditions.
Placebo Multiple Dose: Placebo (tablet) is administered daily for 7 consecutive days.
Study summary
This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and/or food.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Capable of giving informed consent
* Agrees to use effective contraception
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m2
* Healthy by medical evaluation and medical history
* Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20%
* Can swallow tablets and has suitable venous access for blood sampling
Exclusion Criteria:
* Has dietary requirements that may be difficult to accommodate
* Is a regular user of cannabis or has a history of illicit drug abuse within 1 year
* Has a history of alcohol abuse or binge drinking within 6 months
* Is a regular user of tobacco or nicotine-containing products
* Unwilling or unable to comply with the lifestyle guidelines described in the protocol
* Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator
* Has any concurrent disease or condition or physical, psychological, mental, and/or social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study
* Has received a blood transfusion within 1 year
* Has donated whole blood within 6 months or plasma within 30 days
* Requires prescription medication or regular use of non-prescription medication
* Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study
Primary outcome measure(s)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) — From first dose of study drug through the last study visit, approximately 15 days. An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and before the last study visit.
Number of Participants with Serious TEAEs — From first dose of study drug through the last study visit, approximately 15 days. A serious AE (SAE) is defined as any AE that, at any dose, meets one or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital anomaly or birth defect; or any important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
Number of Participants with Clinically Significant Changes in Physical Examination — From the first dose of study drug through the last study visit; approximately 15 days. Abnormalities in physical examinations were based on investigator's discretion.
Number of Participants with Clinically Significant Changes in Safety Laboratory Values — From first dose of study drug through last study visit, approximately 15 days. Safety laboratory evaluations included blood counts, serum chemistries, coagulation studies, and urinalyses. Determination of clinical significance was based on investigator discretion.
Number of Participants with Clinically Significant Changes in Vital Signs — From the first dose of study drug through the last study visit, approximately 15 days. Vital signs included heart rate, respiratory rate, blood pressure, and temperature. Determination of clinical significance was based on investigator discretion.
Number of Participants with Clinically Significant Changes in Electrocardiograms — From the first dose of study drug through the last study visit, approximately 15 days. Electrocardiograms are tests that measure the electrical activity of the heart. Determination of clinical significance was based on investigator discretion.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.