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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1177-8044 | Registry Identifier | WHO |
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The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.
The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.
The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences:
Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period.
This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-935 300 mg (Tablets Fed+Tablets Fasted+Solution Fasted) | Experimental | TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 3. |
|
| TAK-935 300 mg (Tablets Fasted+Solution Fasted+Tablets Fed | Experimental | TAK-935 300 mg, tablets, orally under fasted state on Day 1 of Intervention Period 1, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 2, followed by a washout period of at least 3 days, further followed by TAK-935 300 mg tablets, orally, 30 minutes after high-fat meal on Day 1 of Intervention Period 3. |
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| TAK-935 300 mg (Solution Fasted+Tablets Fed+Tablets Fasted) | Experimental | TAK-935 300 mg, solution, orally, in fasted state on Day 1 of Intervention Period 1, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, 30 minutes after a high-fat meal on Day 1 of Intervention Period 2, followed by washout period of at least 3 days, further followed by TAK-935 300 mg, tablets, orally, under fasted state on Day 1 of Intervention Period 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-935 Tablets | Drug | Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-935 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Baseline up to 30 days after last dose of study drug (Day 39) | |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose |
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Inclusion Criteria:
1. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening and Day -2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | United States |
Healthy participants were enrolled in 1 of the 3 treatment sequences that determined the order of the three treatments received: TAK-935 300 milligram (mg) tablets in fasted state, TAK-935 300 mg tablets in fed state and TAK-935 300 mg solution in fasted state.
Participants took part in the study at 1 investigative site in the United States from 12 September 2016 to 09 November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted | TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. |
| FG001 | TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed | TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3. |
| FG002 | TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted | TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 (3 Days) |
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| Washout Period 1 (at Least 3 Days) |
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| Intervention Period 2 (3 Days) |
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| Washout Period 2 (at Least 3 Days) |
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| Intervention Period 3 (3 Days) |
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The safety analysis set included all participants who were enrolled and received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted | TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-935 | The pharmacokinetic (PK) set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its metabolite (M-I). | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-935 300 mg Tablets Fed | TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| TAK-935 Oral Solution | Drug | Oral solution |
|
| Baseline up to Day 11 |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose. | Baseline up to Day 11 |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose | Baseline up to Day 11 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed | TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3. |
| BG002 | TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted | TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| Smoking Classification | Count of Participants | Participants |
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| No Alcohol Consumption | Count of Participants | Participants |
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| No Xanthine/Caffeine Consumption | Count of Participants | Participants |
|
| Female Reproductive Status | Count of Participants | Participants |
|
| OG002 | TAK-935 300 mg Solution Fasted | TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. |
|
|
|
| Primary | AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935 | The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I. | Posted | Mean | Standard Deviation | nanogram hours per milliliter (ng*hr/mL) | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
|
|
|
| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935 | The PK analysis set where data on Day 1 was available. The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose |
|
|
|
|
| Secondary | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | The safety analysis set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Baseline up to 30 days after last dose of study drug (Day 39) |
|
|
|
| Secondary | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | The safety analysis set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Baseline up to Day 11 |
|
|
|
| Secondary | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose. | The safety analysis set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Baseline up to Day 11 |
|
|
|
| Secondary | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose | The safety analysis set included all participants who were enrolled and received study drug. | Posted | Number | percentage of participants | Baseline up to Day 11 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | TAK-935 300 mg Tablets Fasted | TAK-935 3*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG002 | TAK-935 300 mg Solution Fasted | TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3. | 0 | 9 | 0 | 9 | 0 | 9 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale. |
| ANOVA |
| 0.281 |
| LS Mean Ratio |
| 0.889 |
| 2-Sided |
| 90 |
| 0.738 |
| 1.070 |
| Superiority or Other |
ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale. |
| ANOVA |
| 0.355 |
| LS Mean Ratio |
| 0.894 |
| 90 |
| 0.726 |
| 1.100 |
| Superiority or Other |