PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, 21225, United States
NCT Number: NCT07023029
Novo Nordisk is developing a new study medicine, Etavopivat, to treat individuals with sickle cell disease (SCD). The purpose of the study is to determine the effect of Etavopivat on the electrical activity of the heart in healthy participants. The study comprises two parts: Part A and Part B. Part A investigates the safety of a high dose of Etavopivat. In this phase, participants will receive either a single dose of Etavopivat or a placebo. Which treatment the participant gets is decided by chance. In Part B, participants will get four different treatments on four different occasions: Etavopivat in 2 different doses (the new medicine that cannot be prescribed), a dummy medicine (placebo), and an already approved medicine (moxifloxacin). The order of the 4 study medicines is decided by chance. There will be a break of 7 days between each treatment. For Part A, the study duration will be from 10 to 36 days, and for Part B, the study duration will be from 27 to 53 days.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21225, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A minimum of 20% African-American participants will be included in each part of this study.
Efforts will be made to include at least 40 percentage (%) of each sex into each part of the study.
Etavopivat will be administered orally.
Moxifloxacin will be administered orally.
Placebo matching Etavopivat will be administered orally.
Time frame: From dosing (Day 1) until end of study (Day 8)
Measured as count of events.
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Measured as milliseconds.
Time frame: From dosing (Day 1) until end of study (Day 8)
Measured as count of treatment-emergent clinically significant abnormal findings in ECGs.
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after investigational medicinal product (IMP) administration
Measured as nanograms per milliliter (ng/mL).
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Measured as hours*nanograms per milliliter (h*ng/mL).
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Measured as h*ng/mL.
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Measured as hours.
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Measured as hours.
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Measured as liters per hour (L/h).
Time frame: Day 1 (Part B)/ From day 1 to day 5 (Part A) after IMP administration
Measured as liters (L).
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post etavopivat/ etavopivat placebo dose on day 1 to day 23
Measured as count of treatment emergent changes of ECG morphology.
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Measured as milliseconds.
Time frame: From pre-dose to post moxifloxacin dose on day 1 to day 23
Measured as count of treatment emergent changes of ECG morphology.
Time frame: From pre-dose to post etavopivat/etavopivat placebo dose on day 1 to day 23
Measured as milliseconds.
Novo Nordisk A/S
Industry
A Study to Assess the Effect of Etavopivat on Cardiac Repolarisation in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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