Status:
RECRUITING
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
12-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This ...
Detailed Description
This is a global, randomized, Phase I/II study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary food effect of single-agent ITU512 in adult healthy par...
Eligibility Criteria
Inclusion
- Key
- Part 1 (Healthy participants)
- Healthy male participants and female participants of non-childbearing potential between 18-55 years of age
- In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laboratory tests
- Participants must weigh at least 50 kg at screening and first baseline (admission) and must have a body mass index (BMI) within the range of 18.0-32.0 kg/m2 inclusive.
- Part 2 (Sickle Cell Disease)
- \- Male and female participants with a diagnosis of sickle cell disease
- Key
Exclusion
- Part 1 (Healthy participants)
- QTcF ≥ 450 msec (as a mean value of triplicates)
- History of arrhythmias
- History of significant illness which has not resolved within two (2) weeks prior to initial dosing
- Women of child-bearing potential (WOCBP)
- Part 2 (Sickle Cell Disease)
- Current use of hydroxyurea/hydroxycarbamide (HU/HC)
- QTcF ≥ 450 msec (as a mean value of triplicates)
- History of arrhythmias
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 19 2029
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT06546670
Start Date
August 15 2024
End Date
December 19 2029
Last Update
September 17 2025
Active Locations (1)
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1
Quotient Sciences Sea View
Miami, Florida, United States, 33126