A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
About this study
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 will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).
- Condition
- Sickle Cell Disease
- Tested
- ITU512, Placebo
- Sponsor
- Novartis Pharmaceuticals
Who can join
- Age
- 12 to 55 years
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 9
- Minimum age: 12 years
- Maximum age: 55 years
- Study condition: Sickle Cell Disease
- 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
Exclusion 8
- 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)
- Other protocol-defined inclusion/exclusion criteria may apply.
Where
10 sites, 9 recruiting
Novartis Investigative Site
Adana, Yuregir, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye)
University of Alabama Birmingham
Birmingham, Alabama, United States
Boston Childrens Hospital
Boston, Massachusetts, United States
Levine Cancer Insitute Carolinas Healthcare System
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
and 4 more sites on ClinicalTrials.gov
Contact
-
Novartis Pharmaceuticals
1-888-669-6682 novartis.email@novartis.com
-
Novartis Pharmaceuticals
+41613241111
Potential match only. Final eligibility is determined by the study team.