Clinical trial NCT06433661: A Research Study of the Effect of Food on Etavopivat in Healthy Participants
Official title: A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers Sickle Cell Disease, Thalassemia
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).


Eligibility criteria: Inclusion Criteria:

* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.
* Body weight greater than or equal to (≥) 40.0 kilogram (kg) at screening.
* Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
* Participation (i.e., signed informed consent) in any other interventional clinical study within 30 days or 5 times the half-life of the previous investigational medicinal product (IMP) (if known), whichever is longer before screening.
* Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
* Use of tobacco and nicotine products, defined as any of the below:
* Has used any product containing tobacco or nicotine within 90 days prior to screening,
* Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study,
* Positive nicotine test at screening.
* Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study.
* Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study.

Primary outcomes:
measure: AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
measure: Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
Secondary outcomes:
measure: AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
measure: tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
measure: t1/2, etavopivat: Terminal half-life for etavopivat after a single dose
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
measure: CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
measure: Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
timeFrame: From 0 to 120 hours after IMP administration (V2/V6)
measure: Number of adverse events
timeFrame: From IMP administration on day 1 to completion of the end of study visit (V10)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON-Salt Lake City
state: Utah
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: