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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-2466 | Other Identifier | World Health Organization (WHO) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment: Etavopivat dose 2 | Experimental | Participants will receive a single dose of oral etavopivat. |
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| Moderate hepatic impairment: Etavopivat dose 2 | Experimental | Participants will receive a single dose of oral etavopivat. |
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| Healthy matched controls: Etavopivat dose 2 | Experimental | Participants will receive a single dose of oral etavopivat. |
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| Severe hepatic impairment: Etavopivat dose 1 | Experimental | Participants will receive a single dose of oral etavopivat. |
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| Healthy matched controls: Etavopivat dose 1 | Experimental | Participants will receive a single dose of oral etavopivat. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etavopivat | Drug | Participants will receive a single dose of etavopivat orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose (AUC0-inf, etavopivat) | Measured in hours*nanogram per milliter (h*ng/mL). | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Maximum observed etavopivat plasma concentration after a single dose (Cmax, etavopivat) | Measured in nanogram per milliter (ng/mL). | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the etavopivat plasma concentration-time curve from 0 hours to the last quantifiable concentration after a single dose (AUC0-last, etavopivat) | Measured in h*ng/mL. | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Time to maximum observed etavopivat plasma concentration after a single dose (tmax, etavopivat) |
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Inclusion Criteria:
Specific inclusion criteria only for participants with hepatic impairment:
Specific inclusion criterion only for participants with normal hepatic function:
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and laboratory safety tests performed during screening visit, as judged by the investigator.
Exclusion Criteria:
Known or suspected hypersensitivity to study intervention or related products.
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 interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer, before screening.
Any disorder, unwillingness or inability, except for conditions associated with hepatic impairment in the group of participants with compromised hepatic function, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Participant is unable to refrain from or anticipates the use of, for 7 days prior to dosing and throughout the study, any drug known to be:
Participant is unable to refrain from or anticipates the use of, for 28 days prior to dosing and throughout the study, any drug known to be:
Participant is unable to refrain from or anticipates the use of any medications or substances prohibited in the study.
Specific exclusion criterion only for participants with hepatic impairment:
- Clinical signs of an acute hepatitis (viral as well as non-viral) or positive tests of hepatitis B virus surface antigen (HBsAg) (unless hepatitis B virus titre is negative) or antibody tests of hepatitis C virus (HCV-Ab) (unless negative polymerase chain reaction [PCR] for hepatitis C virus).
Specific exclusion criteria only for participants with normal hepatic function:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cure Clinical Research LLC | Orange | California | 92866 | United States | ||
| Orlando Clinical Research Center |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Measured in hours. |
| From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Terminal half-life for etavopivat after a single dose (t1/2, etavopivat) | Measured in hours. | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Apparent plasma clearance of etavopivat after a single dose (CL/Fetavopivat) | Measured in liter per hour (L/h). | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values (Vz/Fetavopivat) | Measured in liter (L). | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Number of adverse events (AEs) | Measured as count of events. | From IMP administration on day 1 to completion of the end of study visit (day 9) |
| Orlando |
| Florida |
| 32806 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Amer. Rrsch Corp-TX Liver Inst | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |