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

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).

Conditions

Sickle Cell Disease

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Miami

Quotient Sciences Sea View, Miami, Florida, United States, 33126

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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)
  • * Current use of hydroxyurea/hydroxycarbamide (HU/HC)
  • * QTcF ≥ 450 msec (as a mean value of triplicates)
  • * History of arrhythmias

Ages Eligible for Study

12 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Novartis Pharmaceuticals,

Study Record Dates

2029-04-18