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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1165-3720 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4 Formulation C tablet.
The drug being tested in this study is called TAK-385. In this study, two new formulations of TAK-385 are being evaluated under fasted and fed conditions, relative to a previous formulation of TAK-385, to assess its bioavailability and how it is processed by the body. This study will look at lab results of people who take TAK-385.
The study will enroll approximately 54 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups (Arms). Participants in Arm 1 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4 Formulation B 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation B 120 mg tablet under fed conditions. Participants in Arm 2 will receive TAK-385 T2 Formulation 120 mg tablet (80mg + 40mg tablets) under fasted conditions, TAK-385 T4 Formulation C 120 mg tablet under fasted conditions, and TAK-385 T4 Formulation C 120 mg tablet under fed conditions. Participants in each arm will be randomized to receive study drug in one of 6 treatment sequences. Study medication will be administered as a single dose on Days 1, 11 and 21. There will be a 10-day washout period between each dose.
This single-centre trial will be conducted in the United States. The overall time to participate in this study is 51 days. Participants will make 10 visits to the clinic, including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: T2-A + T4B-B + T4B-C | Experimental | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose. |
|
| Arm 2: T2-A + T4C-D + T4C-E | Experimental | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-385 T2 Formulation | Drug | TAK-385 T2 Formulation tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-385 | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose | |
| AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385 | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose | |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
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Inclusion Criteria:
Age 18 to 55 years, inclusive, at the time of consent.
Healthy adult male, as determined by a physician evaluation that includes:
Weight ≥ 55 kg and body mass index (BMI) between 18.0 and 32.0 kg/m^2 inclusive, at Screening.
Nonsmoker for at least 2 years and does not use nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Suitable venous access for the study-required blood sampling.
Abstains from behavior that increases susceptibility to contract blood-borne pathogens (eg, obtaining a tattoo or participating in unsafe needle use for any purpose) during the 28 days before study entry.
In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
Healthy participants were enrolled equally in 1 of 2 treatment arms each with 6 sequences that determined the order of administration of TAK-385 tablet formulations. Arm 1: T2 fasted, T4 B fasted or T4 B fed and Arm 2: T2 fasted, T4 C fasted or T4 C fed.
Participants took part in the study at 1 investigative site in the United States from 02 March 2015 to 11 June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: T2-A + T4B-B + T4B-C | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose. |
| FG001 | Arm 2: T2-A + T4C-D + T4C-E | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
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Safety population: all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: T2-A + T4B-B + T4B-C | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose. |
| 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-385 | Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
|
From Day 1 to 30 days after the last dose of study drug (Up to 51 days)
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 | Arm 1: T2 Formulation Fasted | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | MedDRA 18.0 | 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-385 T4 Formulation B | Drug | TAK-385 T4 Formulation B tablets |
|
| TAK-385 T4 Formulation C | Drug | TAK-385 T4 Formulation C tablets |
|
| From Day 1 to 30 days after the last dose of study drug (Up to 51 days total) |
| Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant | Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range. | Baseline and Days 4, 10, 14, 20, 24 and 26 |
| Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant | A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant. | Days 1, 11, 21 and 26 |
| Percentage of Participants With Markedly Abnormal Vital Sign Measurements | The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study. | From Day 1 to Day 26 |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385 | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
| Terminal Phase Elimination Half-Life (T1/2) for TAK-385 | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
| Oral Clearance (CL/F) for TAK-385 | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| BG001 | Arm 2: T2-A + T4C-D + T4C-E | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Arm 1: T4 Formulation B Fed | T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). |
| OG003 | Arm 2: T2 Formulation Fasted | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). |
| OG004 | Arm 2: T4 Formulation C Fasted | T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). |
| OG005 | Arm 2: T4 Formulation C Fed | T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). |
|
|
|
| Primary | AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385 | PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng•hr/mL | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
|
|
|
|
| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385 | PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
|
|
|
|
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | From Day 1 to 30 days after the last dose of study drug (Up to 51 days total) |
|
|
|
| Secondary | Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant | Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline and Days 4, 10, 14, 20, 24 and 26 |
|
|
|
| Secondary | Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant | A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Days 1, 11, 21 and 26 |
|
|
|
| Secondary | Percentage of Participants With Markedly Abnormal Vital Sign Measurements | The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | From Day 1 to Day 26 |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385 | Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications. | Posted | Median | Full Range | hours | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
|
|
|
| Secondary | Terminal Phase Elimination Half-Life (T1/2) for TAK-385 | Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications. | Posted | Mean | Standard Deviation | hours | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
|
|
|
| Secondary | Oral Clearance (CL/F) for TAK-385 | Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters (L)/hr | Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose |
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| EG001 | Arm 1: T4 Formulation B Fasted | T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). | 0 | 27 | 2 | 27 |
| EG002 | Arm 1: T4 Formulation B Fed | T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). | 0 | 27 | 2 | 27 |
| EG003 | Arm 2: T2 Formulation Fasted | T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). | 0 | 27 | 1 | 27 |
| EG004 | Arm 2: T4 Formulation C Fasted | T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). | 0 | 27 | 1 | 27 |
| EG005 | Arm 2: T4 Formulation C Fed | T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21). | 0 | 27 | 2 | 27 |
| Toothache | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 18.0 | 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.
| Geometric Mean Ration |
| 77.99 |
| 2-Sided |
| 90 |
| 64.29 |
| 94.61 |
T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) * 100 |
| No |
| Superiority or Other |
| Geometric Mean Ratio | 81.08 | 2-Sided | 90 | 64.21 | 102.37 | T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) * 100 | No | Superiority or Other |
| Geometric Mean Ratio | 92.78 | 2-Sided | 90 | 76.48 | 112.55 | T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) * 100 | No | Superiority or Other |
| Geometric Mean Ratio |
| 78.09 |
| 2-Sided |
| 90 |
| 64.53 |
| 94.51 |
T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) * 100 |
| No |
| Superiority or Other |
| Geometric Mean Ratio | 81.16 | 2-Sided | 90 | 64.36 | 102.34 | T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) * 100 | No | Superiority or Other |
| Geometric Mean Ratio | 92.99 | 2-Sided | 90 | 76.84 | 112.54 | T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) * 100 | No | Superiority or Other |
| SAEs |
|
| Chloride_Normal to Low |
|
| Creatinine_Normal to High |
|
| Sodium_Normal to High |
|
| Urate_Normal to Low |
|
| Urate_Normal to High |
|
| Basophils_Normal to High |
|
| Lymphocytes_Normal to High |
|
| Monocytes_Normal to High |
|
| Absolute Monocytes_Normal to High |
|
| Neutrophils_Normal to Low |
|
| Absolute neutrophils_Normal to Low |
|
| Occult blood_Normal to Abnormal |
|
| Specific gravity_Normal to Abnormal |
|