Etavopivat
DrugParticipants will receive a single dose of etavopivat orally.
NCT Number: NCT06336018
The study investigates an investigational drug called etavopivat in participants with hepatic impairments and participants with normal hepatic function (matched controls). During the study, all participants will be given a single oral dose of etavopivat. All participants will take the etavopivat orally together with water. After dosing, the study will last for 7 to 9 days.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Cure Clinical Research LLC, Orange, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Specific inclusion criteria only for participants with hepatic impairment:
Specific inclusion criterion only for participants with normal hepatic function:
Exclusion criteria
Specific exclusion criterion only for participants with hepatic impairment:
Specific exclusion criteria only for participants with normal hepatic function:
Participants will receive a single dose of etavopivat orally.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in hours*nanogram per milliter (h*ng/mL).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in nanogram per milliter (ng/mL).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in h*ng/mL.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in hours.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in hours.
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in liter per hour (L/h).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured in liter (L).
Time frame: From IMP administration on day 1 to completion of the end of study visit (day 9)
Measured as count of events.
Novo Nordisk A/S
Industry
A Multi-centre, Open-label, Parallel-group Study Investigating the Pharmacokinetics, Safety and Tolerability After a Single Dose of Oral Etavopivat in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Participants With Normal Hepatic Function
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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