Healthy Volunteers
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels in healthy participants.
Detailed description
This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose study in healthy participants. The study is the first TAK-648 study in humans and is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of TAK-648 to healthy participants. The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe and well-tolerated single dose. This study measured how much of the study drug got into the blood stream and how long it took the body to get rid of it. Information about any side effects that may have occurred was also collected. This study was a randomized dose-rising study which means that the first group of research participants was assigned by chance to receive either the study drug or placebo. Placebo is a solution that looks like the study drug but has no active ingredient. The lowest dose of the study drug or placebo was given to the 1st group of participants (1st cohort) and a higher dose was given to the next group until all the doses of the study drug were tested. TAK-648 was dosed in 5 sequential cohorts with escalating doses from the lowest dose given in Cohort 1 to higher doses given in the subsequent cohort. Doses could be adjusted based on available safety, tolerability, and pharmacokinetic (PK) data. Approximately 40 healthy male and female participants were planned for enrollment with 8 subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The study included 5 cohorts. This single-center trial was conducted in the United States. The overall time to participate in this study was up to 45 days. Participants made multiple visits to the clinic, including one 5-day period of confinement to the clinic. All participants were contacted by telephone 14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up assessment.
Interventions
DRUGTAK-648
TAK-648 Solution
DRUGTAK-648 Placebo
TAK-648 placebo-matching solution
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is a healthy adult male or non-pregnant, non-lactating female. 2. Is aged 18 to 55 years, inclusive. 3. Weighs at least 55 kg (121 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive. 4. Has a systolic blood pressure \>90 and ≤150 mm Hg and a diastolic blood pressure of \>60 and ≤90 mm Hg at Screening and at Check-in (Day -2). 5. Has a calculated creatinine clearance \>60 mL/min at Screening and Check-in (Day -2).
Exclusion criteria
1. Has a known hypersensitivity to any component of the formulation of TAK-648, phosphodiesterase inhibitors or Listerine strips. 2. Has significant medical histories or currently uncontrolled clinical conditions, which may not be safe for participant to participate in the study, may impact the participant's ability to participate in the study; may influence absorption of the study drug, or may potentially confound the study results. 3. Has a history of persistent, chronic or intermittent nausea, vomiting, or diarrhea or had a current or recent (within 6 months) gastrointestinal disease that would influence the absorption of drugs 4. Has a diagnosis of major depression, bipolar disorder, or anxiety disorders or received any medication to treat any psychological disorders within 1 year prior to Screening. 5. Has abnormal laboratory values that suggest a clinically significant underlying disease or has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2.5 times the upper limits of normal. 6. Use of any excluded medications, supplement, or food product outlined in the protocol. 7. Use of new medications during the course of the study including through the Follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | Day 1 to Day 4 | Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. |
| Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | Day 1 to Day 14 | 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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Day 1 to Day 4 | The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study. |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | Day 1 to Day 4 | Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm). |
Secondary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-648 | Multiple time-points (up to 72 hours) post-dose |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 | Multiple time-points (up to 72 hours) post-dose |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 | Multiple time-points (up to 72 hours) post-dose |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 | Multiple time-points (up to 72 hours) post-dose |
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 19 August 2014 to 08 July 2015.
Pre-assignment details
Healthy Volunteers were enrolled in 1 of 6 treatment groups, once a day placebo, TAK-648 0.05 mg, 0.15 mg, 0.35 mg, 0.7 mg or 0.85 mg.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: TAK-648 0.05 mg TAK-648 0.05 mg, solution, orally, once on Day 1. | 6 |
| Cohort 2: TAK-648 0.15 mg TAK-648 0.15 mg, solution, orally, once on Day 1. | 6 |
| Cohort 3: TAK-648 0.35 mg TAK-648 0.35 mg, solution, orally, once on Day 1. | 6 |
| Cohort 4: TAK-648 0.7 mg TAK-648 0.7 mg, solution, orally, once on Day 1. | 6 |
| Cohort 5: TAK-648 0.85 mg TAK-648 0.85 mg, solution, orally, once on Day 1. | 5 |
| Cohort 1-5: Placebo TAK-648 placebo-matching solution, orally, once on Day 1. | 10 |
| Total | 39 |
Baseline characteristics
| Characteristic | Cohort 1: TAK-648 0.05 mg | Cohort 5: TAK-648 0.85 mg | Cohort 1-5: Placebo | Total | Cohort 4: TAK-648 0.7 mg | Cohort 3: TAK-648 0.35 mg | Cohort 2: TAK-648 0.15 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 39.0 years STANDARD_DEVIATION 13.21 | 45.0 years STANDARD_DEVIATION 11.51 | 36.2 years STANDARD_DEVIATION 11.1 | 37.5 years STANDARD_DEVIATION 10.86 | 37.0 years STANDARD_DEVIATION 9.78 | 37.5 years STANDARD_DEVIATION 9.07 | 32.5 years STANDARD_DEVIATION 11.08 |
| Body Mass Index (BMI) | 24.3 kg/m^2 STANDARD_DEVIATION 3.6 | 26.0 kg/m^2 STANDARD_DEVIATION 2.26 | 24.8 kg/m^2 STANDARD_DEVIATION 3.03 | 25.0 kg/m^2 STANDARD_DEVIATION 2.69 | 25.3 kg/m^2 STANDARD_DEVIATION 2.73 | 25.4 kg/m^2 STANDARD_DEVIATION 2.37 | 24.5 kg/m^2 STANDARD_DEVIATION 2.42 |
| Height | 177.2 cm STANDARD_DEVIATION 9.24 | 170.6 cm STANDARD_DEVIATION 12.26 | 176.4 cm STANDARD_DEVIATION 8.46 | 172.0 cm STANDARD_DEVIATION 10.19 | 163.3 cm STANDARD_DEVIATION 8.21 | 172.2 cm STANDARD_DEVIATION 11.82 | 169.0 cm STANDARD_DEVIATION 8.58 |
| Hip Circumference | 99.33 cm STANDARD_DEVIATION 6.683 | 102.20 cm STANDARD_DEVIATION 4.207 | 98.63 cm STANDARD_DEVIATION 7.121 | 99.47 cm STANDARD_DEVIATION 6.18 | 102.83 cm STANDARD_DEVIATION 4.956 | 98.50 cm STANDARD_DEVIATION 8.385 | 96.33 cm STANDARD_DEVIATION 3.141 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 2 participants | 3 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 1 participants | 3 participants | 9 participants | 1 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 participants | 1 participants | 0 participants | 12 participants | 4 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Non-Hispanic and Latino | 4 participants | 4 participants | 10 participants | 27 participants | 2 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized White | 4 participants | 4 participants | 5 participants | 25 participants | 5 participants | 4 participants | 3 participants |
| Region of Enrollment United States | 6 participants | 5 participants | 10 participants | 39 participants | 6 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 2 Participants | 11 Participants | 4 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants | 28 Participants | 2 Participants | 5 Participants | 5 Participants |
| Waist Circumference | 86.83 cm STANDARD_DEVIATION 9.174 | 95.00 cm STANDARD_DEVIATION 3.391 | 88.06 cm STANDARD_DEVIATION 10.865 | 87.91 cm STANDARD_DEVIATION 8.42 | 86.17 cm STANDARD_DEVIATION 7.548 | 90.00 cm STANDARD_DEVIATION 5.762 | 82.50 cm STANDARD_DEVIATION 6.863 |
| Waist to Hip Ratio | 0.87 ratio STANDARD_DEVIATION 0.037 | 0.93 ratio STANDARD_DEVIATION 0.034 | 0.89 ratio STANDARD_DEVIATION 0.069 | 0.88 ratio STANDARD_DEVIATION 0.061 | 0.84 ratio STANDARD_DEVIATION 0.074 | 0.92 ratio STANDARD_DEVIATION 0.038 | 0.86 ratio STANDARD_DEVIATION 0.061 |
| Weight | 76.1 kg STANDARD_DEVIATION 12.39 | 76.1 kg STANDARD_DEVIATION 12.79 | 77.7 kg STANDARD_DEVIATION 14.33 | 74.1 kg STANDARD_DEVIATION 11.71 | 67.1 kg STANDARD_DEVIATION 4.36 | 75.6 kg STANDARD_DEVIATION 12.86 | 70.0 kg STANDARD_DEVIATION 9.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 3 / 6 | 1 / 6 | 0 / 6 | 1 / 5 | 3 / 10 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 10 |
Outcome results
Primary
Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)
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. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Day 1 to Day 14
Population: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | 0 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | 0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | 20.0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE) | 30.0 percentage of participants |
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose
The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.
Time frame: Day 1 to Day 4
Population: Safety Analysis Set included all enrolled participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Hematology | 0 percentage of participants |
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Chemistry | 0 percentage of participants |
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Urinalysis | 0 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Hematology | 16.7 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Chemistry | 0 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Urinalysis | 0 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Hematology | 0 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Chemistry | 0 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Urinalysis | 0 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Hematology | 0 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Chemistry | 0 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Urinalysis | 0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Hematology | 0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Chemistry | 0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Urinalysis | 0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Chemistry | 0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Urinalysis | 0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose | Hematology | 0 percentage of participants |
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose
Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).
Time frame: Day 1 to Day 4
Population: Safety Analysis Set included all enrolled participants who received study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | < Lower Criteria | 33.3 percentage of participants |
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | > Upper Criteria | 0 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | < Lower Criteria | 16.7 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | > Upper Criteria | 0 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | < Lower Criteria | 33.3 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | > Upper Criteria | 0 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | < Lower Criteria | 33.3 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | > Upper Criteria | 0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | < Lower Criteria | 20.0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | > Upper Criteria | 40.0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | < Lower Criteria | 40.0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose | > Upper Criteria | 20.0 percentage of participants |
Primary
Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose
Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Time frame: Day 1 to Day 4
Population: Safety Analysis Set included all enrolled participants who received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | 0 percentage of participants |
| Cohort 2: TAK-648 0.15 mg | Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | 0 percentage of participants |
| Cohort 3: TAK-648 0.35 mg | Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | 0 percentage of participants |
| Cohort 4: TAK-648 0.7 mg | Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | 0 percentage of participants |
| Cohort 5: TAK-648 0.85 mg | Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | 0 percentage of participants |
| Cohort 1-5: Placebo | Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose | 0 percentage of participants |
Secondary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
Population: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TAK-648 0.05 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 | 4.585 ng*hr/mL | Standard Deviation 2.2743 |
| Cohort 2: TAK-648 0.15 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 | 16.813 ng*hr/mL | Standard Deviation 4.6918 |
| Cohort 3: TAK-648 0.35 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 | 28.266 ng*hr/mL | Standard Deviation 9.5872 |
| Cohort 4: TAK-648 0.7 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 | 75.774 ng*hr/mL | Standard Deviation 25.3966 |
| Cohort 5: TAK-648 0.85 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648 | 93.840 ng*hr/mL | Standard Deviation 30.8531 |
Secondary
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
Population: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TAK-648 0.05 mg | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 | 4.452 ng*hr/mL | Standard Deviation 2.2891 |
| Cohort 2: TAK-648 0.15 mg | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 | 16.614 ng*hr/mL | Standard Deviation 4.6927 |
| Cohort 3: TAK-648 0.35 mg | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 | 27.927 ng*hr/mL | Standard Deviation 9.579 |
| Cohort 4: TAK-648 0.7 mg | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 | 75.280 ng*hr/mL | Standard Deviation 25.2406 |
| Cohort 5: TAK-648 0.85 mg | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 | 92.661 ng*hr/mL | Standard Deviation 30.0958 |
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
Population: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Cmax: Maximum Observed Plasma Concentration for TAK-648 | 0.619 ng/mL | Standard Deviation 0.2461 |
| Cohort 2: TAK-648 0.15 mg | Cmax: Maximum Observed Plasma Concentration for TAK-648 | 2.330 ng/mL | Standard Deviation 0.8022 |
| Cohort 3: TAK-648 0.35 mg | Cmax: Maximum Observed Plasma Concentration for TAK-648 | 3.997 ng/mL | Standard Deviation 1.5958 |
| Cohort 4: TAK-648 0.7 mg | Cmax: Maximum Observed Plasma Concentration for TAK-648 | 11.845 ng/mL | Standard Deviation 2.6415 |
| Cohort 5: TAK-648 0.85 mg | Cmax: Maximum Observed Plasma Concentration for TAK-648 | 11.712 ng/mL | Standard Deviation 6.2166 |
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648
Time frame: Multiple time-points (up to 72 hours) post-dose
Population: PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: TAK-648 0.05 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 | 1.000 hours |
| Cohort 2: TAK-648 0.15 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 | 1.500 hours |
| Cohort 3: TAK-648 0.35 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 | 1.000 hours |
| Cohort 4: TAK-648 0.7 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 | 1.000 hours |
| Cohort 5: TAK-648 0.85 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648 | 1.000 hours |