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A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants

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NCT06813924

Sponsored by Novo Nordisk A/S (industry) · NVO — their whole pipeline →.

Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
37actual
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-02-06actualWhen the study began enrolling
Primary completion2025-05-27actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-05-27actualThe whole study's end, after follow-up
First posted2025-02-07actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-09-25actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Healthy Volunteers Sickle Cell Disease, Thalassemia

Interventions

  • Drug: Etavopivat
  • Drug: Digoxin
  • Drug: Pitavastatin
  • Drug: Metformin
  • Drug: Midazolam
  • Drug: Rosuvastatin

Primary outcomes

what the primary-completion date above is the date OF
Cmax, digoxin, SD: Maximum observed digoxin plasma concentration with and without etavopivat at steady state
measured Day 1 and day 3 after digoxin administration
AUC0-inf, digoxin, SD: Area under the digoxin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
measured Day 1 and day 3 after digoxin administration
Cmax, rosuvastatin, SD: Maximum observed rosuvastatin plasma concentration with and without etavopivat at steady state
measured Day 1 after rosuvastatin administration
AUC0-inf, rosuvastatin, SD: Area under the rosuvastatin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
measured Day 1 after rosuvastatin administration
Cmax, midazolam, SD: Maximum observed midazolam plasma concentration without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
measured Day 1 after midazolam administration
AUC0-inf, midazolam, SD: Area under the midazolam plasma concentration-time curve from 0 hours and extrapolated to infinity without etavopivat, with a single dose of etavopivat, and with etavopivat at steady state
measured Day 1 after midazolam administration
Cmax, pitavastatin, SD: Maximum observed pitavastatin plasma concentration with and without etavopivat at steady state
measured Day 1 and day 3 after pitavastatin administration
AUC0-inf, pitavastatin, SD: Area under the pitavastatin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
measured Day 1 and day 3 after pitavastatin administration
Cmax, metformin, SD: Maximum observed metformin plasma concentration with and without etavopivat at steady state
measured Day 1 and day 3 after metformin administration
AUC0-inf, metformin, SD: Area under the metformin plasma concentration-time curve from 0 hours and extrapolated to infinity with and without etavopivat at steady state
measured Day 1 and day 3 after metformin administration

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