Endometriosis, Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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: * TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14 * TAK-385 40 mg and atorvastatin 80 mg on Days 6-14 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.
Interventions
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Each subject must meet all the following inclusion criteria to be enrolled in the study: 1. Age 18 to 55 years, inclusive, at the time of consent. 2. Healthy adult male or female in good health, as determined by a physician evaluation 3. Weight ≥ 45 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening. 4. Nonsmoker and does not use tobacco-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1 | Day 1 (Predose and multiple time points up to 120 hours postdose) | Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
| Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10 | Day 10 (Predose and multiple time points up to 120 hours postdose) | Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
| 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 | Day 1 (Predose and multiple time points up to 120 hours postdose) | Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration. |
| 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 | Day 10 (Predose and multiple time points up to 120 hours postdose) | Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration. |
| AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1 | Day 1 (Predose and multiple time points up to 120 hours postdose) | Area under the plasma concentration-time curve from time 0 to infinity. |
| AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10 | Day 10 (Predose and multiple time points up to 120 hours postdose) | Area under the plasma concentration-time curve from time 0 to infinity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Disposition Half-life (t1/2) of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) | Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. |
| Apparent Total Body Clearance (CL/F) of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) | — |
| Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE) | First dose of study drug through the end of the study (22 days ± 3 days) | 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. |
| Plasma Trough Concentrations for Fluconazole | Days 8 to 12 Predose | Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12. |
| Plasma Trough Concentrations for Atorvastatin | Days 8 to 12 Predose | Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12. |
| Fraction Excreted Unchanged (Fe) of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) | Fraction of TAK-385 excreted in the urine unchanged. |
| Number of Participants With Clinical Significant Changes in Vital Signs | Baseline and First dose of study drug through the end of the study (22 days ± 3 days) | 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. |
| Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings | Baseline and First dose of study drug through Day 15 | A 12-lead ECG was administered on Days 1,9,10,11,15. |
| Number of Participants With Clinical Significant Changes in Laboratory Tests | Baseline and First dose of study drug through the end of the study (22 days ± 3 days) | 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. |
| Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) | Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax. |
| AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Days 1 and 10 (Predose and multiple time points up to 120 hours postdose) | Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration. |
Participant flow
Recruitment details
Participants took part in the study at one investigative site in the United States from 13 March 2014 to 19 April 2014
Pre-assignment details
Healthy participants were enrolled equally in 1 of 2 treatment groups: TAK-385 + fluconazole or TAK-385 + atorvastatin.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | TAK-385 + Fluconazole | TAK-385 + Atorvastatin | Total |
|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 9.74 | 40.2 years STANDARD_DEVIATION 9.71 | 38.8 years STANDARD_DEVIATION 9.72 |
| Body Mass Index (BMI) | 26.466 kg/m^2 STANDARD_DEVIATION 2.296 | 26.567 kg/m^2 STANDARD_DEVIATION 2.838 | 26.516 kg/m^2 STANDARD_DEVIATION 2.548 |
| Height | 163.6 cm STANDARD_DEVIATION 11.51 | 163.3 cm STANDARD_DEVIATION 12.1 | 163.4 cm STANDARD_DEVIATION 11.65 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 3 participants | 5 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 16 participants | 15 participants | 31 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity, Customized White | 18 participants | 16 participants | 34 participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
| Weight | 70.77 kg STANDARD_DEVIATION 9.137 | 71.96 kg STANDARD_DEVIATION 12.693 | 71.36 kg STANDARD_DEVIATION 10.933 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 20 | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 + Fluconazole | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1 | 92.6 ng*hr/mL | Standard Deviation 40.2 |
| TAK-385 + Atorvastatin | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1 | 123.0 ng*hr/mL | Standard Deviation 59.6 |
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.
Time frame: Day 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 + Fluconazole | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10 | 112.0 ng*hr/mL | Standard Deviation 43.4 |
| TAK-385 + Atorvastatin | AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10 | 108.0 ng*hr/mL | Standard Deviation 32.3 |
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.
Time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 + Fluconazole | 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 | 87.4 ng*hr/mL | Standard Deviation 38.1 |
| TAK-385 + Atorvastatin | 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 | 116.0 ng*hr/mL | Standard Deviation 56.3 |
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.
Time frame: Day 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 + Fluconazole | 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 | 104.0 ng*hr/mL | Standard Deviation 40.5 |
| TAK-385 + Atorvastatin | 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 | 99.8 ng*hr/mL | Standard Deviation 31.2 |
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.
Time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 + Fluconazole | Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1 | 10.9 ng/mL | Standard Deviation 9.34 |
| TAK-385 + Atorvastatin | Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1 | 20.1 ng/mL | Standard Deviation 15.1 |
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.
Time frame: Day 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-385 + Fluconazole | Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10 | 14.4 ng/mL | Standard Deviation 10.7 |
| TAK-385 + Atorvastatin | Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10 | 14.1 ng/mL | Standard Deviation 8.41 |
Secondary
Apparent Total Body Clearance (CL/F) of TAK-385
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-385 + Fluconazole | Apparent Total Body Clearance (CL/F) of TAK-385 | Day 1 (n=20, 19) | 502 liters/hour | Standard Deviation 189 |
| TAK-385 + Fluconazole | Apparent Total Body Clearance (CL/F) of TAK-385 | Day 10 (n=19, 19) | 421 liters/hour | Standard Deviation 186 |
| TAK-385 + Atorvastatin | Apparent Total Body Clearance (CL/F) of TAK-385 | Day 1 (n=20, 19) | 420 liters/hour | Standard Deviation 244 |
| TAK-385 + Atorvastatin | Apparent Total Body Clearance (CL/F) of TAK-385 | Day 10 (n=19, 19) | 406 liters/hour | Standard Deviation 144 |
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.
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-385 + Fluconazole | AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Day 1 (n=20,19) | 87.4 ng*hr/mL | Standard Deviation 38.1 |
| TAK-385 + Fluconazole | AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Day 10 (n=19,19) | 104.0 ng*hr/mL | Standard Deviation 40.5 |
| TAK-385 + Atorvastatin | AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Day 1 (n=20,19) | 116.0 ng*hr/mL | Standard Deviation 56.3 |
| TAK-385 + Atorvastatin | AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385 | Day 10 (n=19,19) | 99.8 ng*hr/mL | Standard Deviation 31.2 |
Secondary
Fraction Excreted Unchanged (Fe) of TAK-385
Fraction of TAK-385 excreted in the urine unchanged.
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-385 + Fluconazole | Fraction Excreted Unchanged (Fe) of TAK-385 | Day 1 (n=20, 19) | 1.56 percent of TAK-385 | Standard Deviation 0.72 |
| TAK-385 + Fluconazole | Fraction Excreted Unchanged (Fe) of TAK-385 | Day 10 (n=20, 19) | 1.61 percent of TAK-385 | Standard Deviation 0.813 |
| TAK-385 + Atorvastatin | Fraction Excreted Unchanged (Fe) of TAK-385 | Day 1 (n=20, 19) | 1.99 percent of TAK-385 | Standard Deviation 1.17 |
| TAK-385 + Atorvastatin | Fraction Excreted Unchanged (Fe) of TAK-385 | Day 10 (n=20, 19) | 1.40 percent of TAK-385 | Standard Deviation 0.426 |
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.
Time frame: First dose of study drug through the end of the study (22 days ± 3 days)
Population: Safety population included all randomized participants with at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 + Fluconazole | Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE) | 5 participants |
| TAK-385 + Atorvastatin | Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE) | 6 participants |
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.
Time frame: Baseline and First dose of study drug through Day 15
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 + Fluconazole | Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings | 0 participants |
| TAK-385 + Atorvastatin | Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings | 0 participants |
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.
Time frame: Baseline and First dose of study drug through the end of the study (22 days ± 3 days)
Population: Safety population included all randomized participants with at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 + Fluconazole | Number of Participants With Clinical Significant Changes in Laboratory Tests | 0 participants |
| TAK-385 + Atorvastatin | Number of Participants With Clinical Significant Changes in Laboratory Tests | 0 participants |
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.
Time frame: Baseline and First dose of study drug through the end of the study (22 days ± 3 days)
Population: Safety population included all randomized participants with at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-385 + Fluconazole | Number of Participants With Clinical Significant Changes in Vital Signs | 0 participants |
| TAK-385 + Atorvastatin | Number of Participants With Clinical Significant Changes in Vital Signs | 0 participants |
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.
Time frame: Days 8 to 12 Predose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Atorvastatin | Day 8 | 0.742 ng/mL | Standard Deviation 0.444 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Atorvastatin | Day 9 | 0.753 ng/mL | Standard Deviation 0.351 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Atorvastatin | Day 10 | 0.702 ng/mL | Standard Deviation 0.385 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Atorvastatin | Day 11 | 0.559 ng/mL | Standard Deviation 0.263 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Atorvastatin | Day 12 | 0.536 ng/mL | Standard Deviation 0.203 |
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.
Time frame: Days 8 to 12 Predose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Fluconazole | Day 8 | 6330 ng/mL | Standard Deviation 1100 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Fluconazole | Day 9 | 6540 ng/mL | Standard Deviation 1180 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Fluconazole | Day 10 | 7030 ng/mL | Standard Deviation 1270 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Fluconazole | Day 11 | 7030 ng/mL | Standard Deviation 1540 |
| TAK-385 + Fluconazole | Plasma Trough Concentrations for Fluconazole | Day 12 | 7200 ng/mL | Standard Deviation 1560 |
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.
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAK-385 + Fluconazole | Terminal Disposition Half-life (t1/2) of TAK-385 | Day 1 (n=20, 19) | 34.8 hours | Standard Deviation 3.38 |
| TAK-385 + Fluconazole | Terminal Disposition Half-life (t1/2) of TAK-385 | Day 10 (n=19, 19) | 39.2 hours | Standard Deviation 3.57 |
| TAK-385 + Atorvastatin | Terminal Disposition Half-life (t1/2) of TAK-385 | Day 1 (n=20, 19) | 36.5 hours | Standard Deviation 3.74 |
| TAK-385 + Atorvastatin | Terminal Disposition Half-life (t1/2) of TAK-385 | Day 10 (n=19, 19) | 41.1 hours | Standard Deviation 5.11 |
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.
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| TAK-385 + Fluconazole | Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Day 1 (n=20, 20) | 1.00 hours |
| TAK-385 + Fluconazole | Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Day 10 (n=19, 19) | 1.00 hours |
| TAK-385 + Atorvastatin | Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Day 1 (n=20, 20) | 1.00 hours |
| TAK-385 + Atorvastatin | Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385 | Day 10 (n=19, 19) | 1.01 hours |