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The purpose of this study is to estimate the relative bioavailability of UCB0022 Formulation 2 (Test) versus Formulation 1 (Reference) in healthy participants following single oral administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence AB | Experimental | Study participants will receive a single oral dose of UCB0022 Formulation 1 (reference) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 2 (test) on Day 15 (dosing day of Period 2) in Treatment sequence A-B. A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2. |
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| Treatment Sequence BA | Experimental | Study participants will receive a single oral dose of UCB0022 Formulation 2 (test) on Day 1 (dosing day of Period 1) and a single oral dose of UCB0022 Formulation 1 (reference) on Day 15 (dosing day of Period 2) in Treatment sequence B-A. A washout period of 14 days is included for elimination of the drug between the single oral administrations of UCB0022 in Periods 1 and 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0022 | Drug | Participants will receive a single oral dose of UCB0022 tablet Formulation 1 and UCB0022 tablet Formulation 2 following a pre-specified sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve of UCB0022 | AUC: Area under the plasma concentration-time curve. | From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2 |
| Area under the plasma concentration-time curve from time 0 to t of UCB0022 | AUC0-t: Area under the plasma concentration-time curve from time 0 to t. | From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2 |
| Maximum observed plasma concentration of UCB0022 | Cmax: Maximum observed plasma concentration. | From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment-emertgent Adverse Events (TEAEs) from Day 1 up to end of the Safety Follow-up (SFU) Period or End of Study (EOS) | A TEAE is defined as any AE with a start date or time on or after the first dose of study intervention until the end of the SFU Period (ie, EOS/SFU Visit). | From Dosing (Day 1) up to SFU period or End of study (EOS) (up to Day 28) |
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Inclusion Criteria:
Participant must be minimum 18 years and maximum 55 years of age inclusive at the time of signing the informed consent form (ICF).
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants have a blood pressure (BP) and heart rate (HR) during the Screening Period or before the first dose of study intervention, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90mmHg and 130mmHg, mean diastolic BP ranging between 50mmHg and 80mmHg, and mean HR between 45bpm and 90bpm.
Body weight greater than or equal (≥)45 kilograms (kg) and body mass index within the range 18.0 kilograms per meter square (kg/m2) to 30.0 kg/m2 (inclusive).
A male participant must agree to use contraception during both Periods and for at least 14 days after the final dose of study intervention, and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion Criteria:
alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) >1.0×upper limit of normal (ULN) (isolated bilirubin <1.5×ULN is acceptable if fractionated and direct bilirubin <35%).
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 0018445992273 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UP0159 1 | San Antonio | Texas | 78209 | United States |
Due to the small sample size in this trial, individual patient-level data cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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