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It is hoped that TAK-994 will eventually help people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day, including falling asleep suddenly. Before then, the sponsor needs to understand how the body processes TAK-994.
The main aims of the study are to learn how the body processes 4 different new forms of TAK-994, when taken with food and without food, compared to a standard form of TAK-994.
At the first visit, the study doctor will check who can take part. Then the participants will be picked for 1 of 3 groups by chance. These groups of participants will take different new forms of TAK-994 and the standard form. They will take these with and without food. This will happen again 3 or 4 times but will take TAK-994 in a different order each time. After each treatment with TAK-994, the study doctors will check the amount of TAK-994 in the blood of the participants, over time. The study doctors will also check if the participants have any side effects from TAK-994.
Participants will wait 5 or more days between each dose to allow time for TAK-994 to completely leave their bodies. Participants will stay in the clinic during their treatment with TAK-994. They will stay in the clinic for 15 days or longer. Participants who have 4 treatments with TAK-994 will stay in the clinic for 20 days or longer.
Then, the clinic will telephone the participants 12 days after their final treatment of TAK-994 to check if they have any health problems.
The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy participants. This study will look at the relative BA of different TAK-994 test formulations relative to the currently used formulation (T1) and the effect of food on the test formulations in healthy participants.
The study will enroll approximately 54 participants. The study consists of three parallel groups (Group 1, Group 2, and Group 3). In each group, one test TAK-994 formulation (T2 formulations in Group 1; T3 formulations in Group 2; and T4 and T5 formulations in Group 3) will be evaluated under fed and fasting condition compared to reference T1 formulation under fasting conditions in a cross-over design. Participants will be randomly assigned into 6 sequences within each group.
This multi-center trial will be conducted in United States. The overall time to participate in this study is approximately 57 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: A1(T1), B(T2), C(T2 Fed) | Experimental | Participants will be randomly placed into 6 sequences within Group 1. All participants in Group 1 will receive TAK-994 as Treatment A1 (T1 Formulation) and Treatment B (T2 Formulation) under fasted conditions and Treatment C (T2 Formulation) under fed conditions at different times within three periods. |
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| Group 2: A2(T1), D(T3), E(T3 Fed) | Experimental | Participants will be randomly placed into 6 sequences within Group 2. All participants in Group 2 will receive TAK-994 as Treatment A2 (T1 Formulation) and Treatment D (T3 Formulation) under fasted conditions and Treatment E (T3 Formulation) under fed conditions at different times within three periods. |
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| Group 3: A3(T1), F(T4), G(T4 Fed), H(T5) | Experimental | Participants will be randomly placed into 6 sequences within Group 3. Participants in Group 3 will receive TAK-994 as Treatment A3 (T1 Formulation), Treatment F (T4 Formulation), and Treatment F (T5 Formulation) under fasted conditions and Treatment G (T4 Formulation) under fed conditions at different times within 4 periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-994 | Drug | T2 formulation. |
| |
| TAK-994 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax : Maximum Observed Plasma Concentration for TAK-994 | Day 1: Pre-dose and at multiple time points (up to 72 hours) post-dose | |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 | Day 1: Pre-dose and at multiple time points (up to 72 hours) post-dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-994 | Day 1: Pre-dose and at multiple time points (up to 72 hours) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least one Treatment-emergent Adverse Event (TEAE) | Day 1 up to 14 days after last dose of study drug (up to Day 33) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Tempe, AZ site | Tempe | Arizona | 85283 | United States | ||
| Celerion Lincoln, NE site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Drug |
T1 formulation. |
|
| TAK-994 | Drug | T3 formulation. |
|
| TAK-994 | Drug | T4 formulation. |
|
| TAK-994 | Drug | T5 formulation. |
|
| Lincoln |
| Nebraska |
| 68502 |
| United States |