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TAK-653 · 2 trials · 2 indications
TMS was a neurophysiologic test for assessing upper motor neuron function. TMS was a noninvasive neuro stimulation method involving the application of brief magnetic pulses to the skull, based on the principles of electromagnetic induction, create an orthogonal electric current that can be sufficient to depolarize neurons and activate neuronal circuits. Single-pulse TMS was used to determine peak-to-peak amplitude of MEP at a stimulation intensity of 120 percent (%) of baseline resting motor threshold (rMT). rMT was defined as the minimum stimulus intensity to evoke an MEP. Change in peak-to peak amplitude of MEP was be assessed by TMS after treatment with 0.5 mg or 6 mg of TAK-653 versus (vs.) matched oral placebo.
The rMT was defined as the minimum stimulus intensity to evoke an MEP. Single-pulse TMS was used to determine rMT. A lower rMT value indicated greater neuronal excitability. TMS was a neurophysiologic test for assessing upper motor neuron function. TMS was a noninvasive neuro stimulation method involving the application of brief magnetic pulses to the skull, based on the principles of electromagnetic induction, create an orthogonal electric current that can be sufficient to depolarize neurons and activate neuronal circuits. Change in rMT was be assessed by TMS after treatment with 0.5 mg or 6 mg of TAK-653 vs. matched oral placebo.
Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).
| Arm | Type | Description |
|---|---|---|
| TAK-653 6 mg + TAK-653 0.5 mg + Placebo + Ketamine 0.5 mg/kg | EXPERIMENTAL | TAK-653 6 milligram (mg) high dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 milligram per kilogram (mg/kg), intravenous infusion, once on Day 1 of Treatment Period 4. A washout of 10 to 15 days will be maintained between each treatment period. |
| TAK-653 6 mg + Placebo + TAK-653 0.5 mg + Ketamine 0.5 mg/kg | EXPERIMENTAL | TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, intravenous infusion, once on Day 1 of Treatment Period 4. A washout of 10 to 15 days will be maintained between each treatment period. |
| TAK-653 0.5 mg + TAK-653 6 mg + Placebo + Ketamine 0.5 mg/kg | EXPERIMENTAL | TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, intravenous infusion, once on Day 1 of Treatment Period 4. A washout of 10 to 15 days will be maintained between each treatment period. |
| TAK-653 0.5 mg + Placebo + TAK-653 6 mg + Ketamine 0.5 mg/kg | EXPERIMENTAL | TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, intravenous infusion, once on Day 1 of Treatment Period 4. A washout of 10 to 15 days will be maintained between each treatment period. |
| Placebo + TAK-653 0.5 mg + TAK-653 6 mg + Ketamine 0.5 mg/kg | EXPERIMENTAL | TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, intravenous infusion, once on Day 1 of Treatment Period 4. A washout of 10 to 15 days will be maintained between each treatment period. |
| Placebo + TAK-653 6 mg + TAK-653 0.5 mg + Ketamine 0.5 mg/kg | EXPERIMENTAL | TAK-653 placebo-matching tablets, orally, once on Day 1 of Treatment Period 1, followed by TAK-653 6 mg high dose tablets, orally, once on Day 1 of Treatment Period 2, further followed by TAK-653 0.5 mg low dose tablets, orally, once on Day 1 of Treatment Period 3, followed by Ketamine 0.5 mg/kg, intravenous infusion, once on Day 1 of Treatment Period 4. A washout of 10 to 15 days will be maintained between each treatment period. |
| Part 1 Cohort 1: TAK-653 0.3 mg | EXPERIMENTAL | TAK-653 0.3 milligram (mg), tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 2: TAK-653 1.0 mg | EXPERIMENTAL | TAK-653 1.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 3: TAK-653 3.0 mg | EXPERIMENTAL | TAK-653 3.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 4: TAK-653 5.0 mg | EXPERIMENTAL | TAK-653 5.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 5: TAK-653 9.0 mg | EXPERIMENTAL | TAK-653 9.0 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. |
| Part 1 Cohort 6: TAK- 653 18 mg | EXPERIMENTAL | TAK-653 18 mg, tablet, orally, once on Day 1 or TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. Dose escalation to be decided (TBD) based on safety, tolerability, and available PK and pharmacodynamics (PD) data from previous cohorts. |
| Part 1 Additional Cohorts: TAK- 653 Placebo | EXPERIMENTAL | TAK-653 placebo-matching tablet, orally, once on Day 1. TAK-653 or placebo will be administered after an overnight fast of approximately at least 10 hours. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Part 2 Cohort 1: TAK-653 0.3 mg | EXPERIMENTAL | TAK-653 0.3 mg, tablet, orally, once on Day 1, and once daily (QD) from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. |
| Part 2 Cohort 2: TAK-653 1.0 mg | EXPERIMENTAL | TAK-653 1.0 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. |
| Part 2 Cohort 3: TAK-653 3.0 mg | EXPERIMENTAL | TAK-653 3.0 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. |
| Part 2 Cohort 4: TAK-653 6 mg | EXPERIMENTAL | TAK-653 6 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Part 2 Cohort 5: TAK-653 9 mg | EXPERIMENTAL | TAK-653 9 mg, tablet, orally, once on Day 1, and QD from Days 6 to 18 or placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Part 2 Additional Cohorts: TAK-653 Placebo | EXPERIMENTAL | TAK-653 placebo-matching tablet, orally, once on Day 1 and QD from Days 6 to 18. Dose escalation TBD based on safety, tolerability, and available PK and PD data from previous cohorts. |
| Name | Type | Description |
|---|---|---|
| TAK-653 | DRUG | TAK-653 tablets. |
| Placebo | DRUG | TAK-653 placebo-matching tablets. |
| Ketamine | DRUG | Ketamine intravenous infusion. |
| TAK-653 Placebo | DRUG | TAK-653 placebo-matching tablets. |
Inclusion Criteria: 1. Must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before the first ...
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TAK-653 is an investigational small molecule being developed for depressive disorder. It has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacodynamic activity. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
TAK-653 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The drug is currently in Phase 1 clinical trials for depressive disorder and healthy volunteer studies.
TAK-653 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy participants in the United Kingdom and another in healthy participants in the Netherlands. The drug remains investigational and has not received FDA approval.
TAK-653 has completed two Phase 1 trials. NCT02561156 was an escalating single and multiple dose study in healthy participants with depressive disorder, enrolling 88 participants in the United Kingdom. NCT03792672 evaluated central nervous system pharmacodynamic activity using transcranial magnetic stimulation in 24 healthy volunteers in the Netherlands.
No, TAK-653 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials were designed to assess safety, tolerability, and pharmacodynamic effects in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory submission.