RECRUITING

A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase I/II Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ITU512 in Healthy Participants and Patients With Sickle Cell Disease

Quick Facts

Study Start:2024-08-15
Study Completion:2029-04-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06546670

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy male participants and female participants of non-childbearing potential between 18-55 years of age
  2. * In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laboratory tests
  3. * 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.
  1. * QTcF ≥ 450 msec (as a mean value of triplicates)
  2. * History of arrhythmias
  3. * History of significant illness which has not resolved within two (2) weeks prior to initial dosing
  4. * Women of child-bearing potential (WOCBP)
  5. * Current use of hydroxyurea/hydroxycarbamide (HU/HC)
  6. * QTcF ≥ 450 msec (as a mean value of triplicates)
  7. * History of arrhythmias

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111

Study Locations (Sites)

Quotient Sciences Sea View
Miami, Florida, 33126
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-15
Study Completion Date2029-04-18

Study Record Updates

Study Start Date2024-08-15
Study Completion Date2029-04-18

Terms related to this study

Keywords Provided by Researchers

  • ITU512
  • Low molecular weight
  • Small molecule
  • Sickle cell disease

Additional Relevant MeSH Terms

  • Sickle Cell Disease