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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1183-0138 | Registry Identifier | WHO |
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This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.
The study enrolled 40 patients. Participants were assigned to one of the two treatment groups:
Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.
This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-385 + fluconazole | Experimental | TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. |
|
| TAK-385 + atorvastatin | Experimental | TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-385 | Drug | TAK-385 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1 | Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Day 1 (Predose and multiple time points up to 120 hours postdose) |
| Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10 | Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Day 10 (Predose and multiple time points up to 120 hours postdose) |
| AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1 | Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration. | Day 1 (Predose and multiple time points up to 120 hours postdose) |
| AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10 | Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration. | Day 10 (Predose and multiple time points up to 120 hours postdose) |
| AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1 | Area under the plasma concentration-time curve from time 0 to infinity. | Day 1 (Predose and multiple time points up to 120 hours postdose) |
| AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
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Inclusion Criteria
Each subject must meet all the following inclusion criteria to be enrolled in the study:
Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
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Healthy participants were enrolled equally in 1 of 2 treatment groups: TAK-385 + fluconazole or TAK-385 + atorvastatin.
Participants took part in the study at one investigative site in the United States from 13 March 2014 to 19 April 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-385 + Fluconazole | TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. |
| FG001 | TAK-385 + Atorvastatin | TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-385 + Fluconazole | TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. |
| BG001 |
| 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 of TAK-385 on Day 1 | Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | Pharmacokinetic (PK)-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (Predose and multiple time points up to 120 hours postdose) |
|
Up to 25 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 | TAK-385 + Fluconazole | TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dermatitis | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C561634 | relugolix |
| D015725 | Fluconazole |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole |
| Drug |
Fluconazole tablets |
|
| Atorvastatin | Drug | Atorvastatin tablets |
|
Area under the plasma concentration-time curve from time 0 to infinity.
| Day 10 (Predose and multiple time points up to 120 hours postdose) |
| First dose of study drug through the end of the study (22 days ± 3 days) |
| Number of Participants With Clinical Significant Changes in Vital Signs | Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure. | Baseline and First dose of study drug through the end of the study (22 days ± 3 days) |
| Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings | A 12-lead ECG was administered on Days 1,9,10,11,15. | Baseline and First dose of study drug through Day 15 |
| Number of Participants With Clinical Significant Changes in Laboratory Tests | Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories. | Baseline and First dose of study drug through the end of the study (22 days ± 3 days) |
| Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax. | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
| AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration. | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
| Terminal Disposition Half-life (t1/2) of TAK-385 | Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
| Apparent Total Body Clearance (CL/F) of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
| Fraction Excreted Unchanged (Fe) of TAK-385 | Fraction of TAK-385 excreted in the urine unchanged. | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
| Plasma Trough Concentrations for Fluconazole | Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12. | Days 8 to 12 Predose |
| Plasma Trough Concentrations for Atorvastatin | Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12. | Days 8 to 12 Predose |
| TAK-385 + Atorvastatin |
TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| TAK-385 + Atorvastatin |
TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. |
|
|
| Primary | Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10 | Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng/mL | Day 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Primary | AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1 | Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Primary | AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10 | Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Primary | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1 | Area under the plasma concentration-time curve from time 0 to infinity. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Primary | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10 | Area under the plasma concentration-time curve from time 0 to infinity. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Secondary | Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. | Safety population included all randomized participants with at least one dose of study drug. | Posted | Number | participants | First dose of study drug through the end of the study (22 days ± 3 days) |
|
|
|
| Secondary | Number of Participants With Clinical Significant Changes in Vital Signs | Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure. | Safety population included all randomized participants with at least one dose of study drug. | Posted | Number | participants | Baseline and First dose of study drug through the end of the study (22 days ± 3 days) |
|
|
|
| Secondary | Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings | A 12-lead ECG was administered on Days 1,9,10,11,15. | Posted | Number | participants | Baseline and First dose of study drug through Day 15 |
|
|
|
| Secondary | Number of Participants With Clinical Significant Changes in Laboratory Tests | Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories. | Safety population included all randomized participants with at least one dose of study drug. | Posted | Number | participants | Baseline and First dose of study drug through the end of the study (22 days ± 3 days) |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Median | Full Range | hours | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Secondary | AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng*hr/mL | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Secondary | Terminal Disposition Half-life (t1/2) of TAK-385 | Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | hours | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Secondary | Apparent Total Body Clearance (CL/F) of TAK-385 | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | liters/hour | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Secondary | Fraction Excreted Unchanged (Fe) of TAK-385 | Fraction of TAK-385 excreted in the urine unchanged. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | percent of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) |
|
|
|
| Secondary | Plasma Trough Concentrations for Fluconazole | Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng/mL | Days 8 to 12 Predose |
|
|
|
| Secondary | Plasma Trough Concentrations for Atorvastatin | Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12. | PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters. | Posted | Mean | Standard Deviation | ng/mL | Days 8 to 12 Predose |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | TAK-385 + Atorvastatin | TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. | 0 | 20 | 6 | 20 |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | 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.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D011758 |
| Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Title | Measurements |
|---|---|
|
| Day 11 |
|
| Day 12 |
|
| Title | Measurements |
|---|---|
|
| Day 11 |
|
| Day 12 |
|