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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-OX-JZNI | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Loxo Oncology, Inc. | INDUSTRY |
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The main purpose of this study is to assess the effect of Pirtobrutinib (LOXO-305) on the heart rate-corrected QT (QTc) interval and to conduct blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib. The study will also evaluate the safety and tolerability of pirtobrutinib. The study will last up to 71 days, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib | Experimental | Pirtobrutinib a single oral dose on Day 1, 12 and 23 following a fast of at least 8 hours prior to and 6 hours after dosing. |
|
| Placebo | Placebo Comparator | Placebo (matched to Pirtobrutinib) a single oral dose on Day 1, 12 and 23 following a fast of at least 8 hours prior to and 6 hours after dosing. |
|
| Moxifloxacin | Active Comparator | Moxifloxacin a single oral dose on Day 1, 12 and 23 following a fast of at least 8 hours prior to and 6 hours after dosing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) | The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect. | Baseline (Predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in (Δ) QTcF | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Change from baseline in (Δ) QTcF was calculated using linear mixed-effects model analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renee Ward, MD, PhD | Loxo Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit 1341 Mockingbird Lane | Dallas | Texas | 75247 | United States | ||
| Covance Clinical Research Unit 3402 Kinsman Blvd |
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A total of 31 participants were enrolled in this study. Participants were randomly assigned to 1 of 6 treatment sequences (ABC, BCA, CAB, ACB, CBA and BAC) where Treatment A was single oral dose of 900 milligrams (mg) pirtobrutinib, Treatment B was single oral dose of 900 mg pirtobrutinib matched placebo and Treatment C was single oral dose of 400 mg moxifloxacin.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: ABC | Participants received a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 12 and a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 23, under fasted conditions. |
| FG001 | Treatment Sequence 2: BCA | Participants received a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 1, followed by a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 12 and a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 23, under fasted conditions. |
| FG002 | Treatment Sequence 3: CAB | Participants received a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 12 and a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 23, under fasted conditions. |
| FG003 | Treatment Sequence 4: ACB | Participants received a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 1, followed by a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 12 and a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 23, under fasted conditions. |
| FG004 | Treatment Sequence 5: CBA | Participants received a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 12 and a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 23, under fasted conditions. |
| FG005 | Treatment Sequence 6: BAC | Participants received a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 12 and a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 23, under fasted conditions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Day 1) |
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| Treatment Period 2 (Day 12) |
| ||||||||||||||||||||||||||||
| Treatment Period 3 (Day 23) |
|
All participants who received 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence: ABC | Participants received a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 12 and a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 23, under fasted conditions |
| 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 | Placebo-corrected Change From Baseline in QT Interval Corrected Using Fridericia's Correction (QTcF) (ΔΔQTcF) | The cardiodynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect. | Pharmacokinetic/Corrected QT interval (PK/QTc) population included all participants who were in both the PK and QT/QTc populations with at least 1 pair of post-dose PK and ΔQTc data from the same time point in at least 1 period as well as participants in the QT/QTc population who received placebo. As per planned analysis, data was planned to be reported only for Treatment A (900 mg pirtobrutinib) concentration for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | milliseconds (msec) | Baseline (Predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
Baseline up to follow-up (up to Day 42)
All participants who received 1 dose of study drug.
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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 | Treatment A: 900 mg Pirtobrutinib | Participants who received a single oral dose of 900 mg pirtobrutinib capsules. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2020 | Jan 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2021 | Jan 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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This is a partially double-blind study (for LOXO-305 only, not moxifloxacin).
| Placebo | Drug | Administered orally |
|
| Moxifloxacin | Drug | Administered orally |
|
| Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Change From Baseline in Heart Rate (ΔHR) | Heart rate is the number of times the ventricles of the heart contract and relax per minute. Change from baseline in heart rate (ΔHR) was calculated using linear mixed-effects model analysis. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Change From Baseline in Pulse Rate (ΔPR) | Pulse rate is number of times heart beats per minute. Pulse rate measurements were performed using the same arm for each reading and measurements were taken after the participant had been resting in the supine position for at least 5 minutes. Change from baseline in pulse rate (ΔPR) was calculated using linear mixed-effects model analysis. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Change From Baseline in QRS Intervals (Δ QRS) | QRS interval in an ECG measured the total time of ventricular depolarization. It begins with Q or R wave and ends at the end of the S wave. Change from baseline in QRS intervals (Δ QRS) was calculated using linear mixed-effects model analysis. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Change From Baseline in Individualized Heart Rate-Corrected QT Interval (ΔQTcS), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcS. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Change From Baseline in Optimized Heart Rate-Corrected QT Interval (ΔQTcI), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcI. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) | Heart rate is the number of times the ventricles of the heart contract and relax per minute. Placebo-corrected change from baseline in heart rate (ΔΔHR) was calculated using linear mixed-effects model analysis. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Placebo-corrected Change From Baseline in Pulse Rate (ΔΔ PR) | Pulse rate is number of times heart beats per minute. Pulse rate measurements were performed using the same arm for each reading and measurements were taken after the participant had been resting in the supine position for at least 5 minutes. Placebo-corrected change from baseline in pulse rate (ΔPR) was calculated using linear mixed-effects model analysis. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Placebo-Corrected Change From Baseline in QRS (ΔΔQRS) | QRS interval in an ECG measured the total time of ventricular depolarization. It begins with Q or R wave and ends at the end of the S wave. Placebo-corrected change from baseline in QRS intervals (ΔΔQRS) was calculated using linear mixed-effects model analysis. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Placebo-corrected Change From Baseline in ΔQTcF (ΔΔQTcF), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Placebo-corrected Change From Baseline in Individualized Heart Rate-Corrected QT Interval (ΔΔQTcS), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcS. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Placebo-corrected Change From Baseline in Optimized Heart Rate-Corrected QT Interval (ΔΔQTcI), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcI. | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Changes | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. Number of participants with potentially clinically significant ECG changes were reported. | Baseline up to Day 33 |
| Number of Participants With Treatment Emergent Changes in T-wave Morphology and U-wave Presence | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. Number of participants with treatment emergent changes in T-wave morphology and U-wave presence were reported. | Baseline up to Day 33 |
| Pharmacokinetic (PK): Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Pirtobrutinib | PK: %AUCextrap was defined as percentage extrapolation for AUC0-inf. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Mean Residence Time (MRT) of Pirtobrutinib | PK: MRT was calculated by the area under the first moment curve divided by the area under the concentration time curve. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was calculated as (CL/F)/Lambda Z. Where, CL/F is the apparent total clearance and lambda Z is the apparent terminal elimination rate constant. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax was defined as the time to reach maximum observed plasma concentration (Cmax) for pirtobrutinib. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib | PK: t1/2 was defined as the terminal elimination phase half-life for pirtobrutinib. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax was defined as the maximum plasma concentration for pirtobrutinib. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC(0-24) was defined as the area under the plasma concentration-time curve from 0 time to 24 hours post-dose. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24 hours post-dose |
| PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 time to last measurable point for pirtobrutinib. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as (Dose/AUC(0-inf))/F. Where AUC(0-inf) is the area under the plasma concentration-time curve from zero to infinity and F is the bioavailability of the drug. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC(0-inf) was defined as the area under the plasma concentration-time curve from 0 to infinity for pirtobrutinib. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib | PK: Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| Treatment Sequence: BCA |
Participants received a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 1, followed by a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 12 and a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 23, under fasted conditions. |
| BG002 | Treatment Sequence: CAB | Participants received a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 12 and a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 23, under fasted conditions. |
| BG003 | Treatment Sequence: ACB | Participants received a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 1, followed by a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 12 and a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 23, under fasted conditions. |
| BG004 | Treatment Sequence: CBA | Participants received a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 12 and a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 23, under fasted conditions. |
| BG005 | Treatment Sequence: BAC | Participants received a single oral dose of 900 mg pirtobrutinib matched placebo (Treatment B) on Day 1, followed by a single oral dose of 900 mg pirtobrutinib (Treatment A) on Day 12 and a single oral dose of 400 mg moxifloxacin (Treatment C) on Day 23, under fasted conditions. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Treatment A: 900 mg Pirtobrutinib | Participants who received a single oral dose of 900 mg Pirtobrutinib capsules. |
|
|
| Secondary | Change From Baseline in (Δ) QTcF | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Change from baseline in (Δ) QTcF was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. Here, 'Number Analyzed' signifies participants who were evaluable at specific timepoints. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Heart Rate (ΔHR) | Heart rate is the number of times the ventricles of the heart contract and relax per minute. Change from baseline in heart rate (ΔHR) was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. Here, 'Number Analyzed' signifies participants who were evaluable at specific timepoints. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (beats/min) | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Pulse Rate (ΔPR) | Pulse rate is number of times heart beats per minute. Pulse rate measurements were performed using the same arm for each reading and measurements were taken after the participant had been resting in the supine position for at least 5 minutes. Change from baseline in pulse rate (ΔPR) was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. Here, 'Number Analyzed' signifies participants evaluable for specific timepoints. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | beats per minute (beats/min) | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
|
|
|
| Secondary | Change From Baseline in QRS Intervals (Δ QRS) | QRS interval in an ECG measured the total time of ventricular depolarization. It begins with Q or R wave and ends at the end of the S wave. Change from baseline in QRS intervals (Δ QRS) was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. Here, 'Number Analyzed' signifies participants evaluable for specific timepoints. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Individualized Heart Rate-Corrected QT Interval (ΔQTcS), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcS. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Optimized Heart Rate-Corrected QT Interval (ΔQTcI), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcI. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
|
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| Secondary | Placebo-corrected Change From Baseline in Heart Rate (ΔΔHR) | Heart rate is the number of times the ventricles of the heart contract and relax per minute. Placebo-corrected change from baseline in heart rate (ΔΔHR) was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and C for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | beats/min | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
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| Secondary | Placebo-corrected Change From Baseline in Pulse Rate (ΔΔ PR) | Pulse rate is number of times heart beats per minute. Pulse rate measurements were performed using the same arm for each reading and measurements were taken after the participant had been resting in the supine position for at least 5 minutes. Placebo-corrected change from baseline in pulse rate (ΔPR) was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and C for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | beats/min | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
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| Secondary | Placebo-Corrected Change From Baseline in QRS (ΔΔQRS) | QRS interval in an ECG measured the total time of ventricular depolarization. It begins with Q or R wave and ends at the end of the S wave. Placebo-corrected change from baseline in QRS intervals (ΔΔQRS) was calculated using linear mixed-effects model analysis. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and C for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
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| Secondary | Placebo-corrected Change From Baseline in ΔQTcF (ΔΔQTcF), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. | PK/QTc population included all participants who were in both the PK and QT/QTc populations with at least 1 pair of post-dose PK and ΔQTc data from the same time point in at least 1 period as well as participants in the QT/QTc population who received placebo. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
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| Secondary | Placebo-corrected Change From Baseline in Individualized Heart Rate-Corrected QT Interval (ΔΔQTcS), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcS. | QT/QTc population included all participants w.ho received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
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| Secondary | Placebo-corrected Change From Baseline in Optimized Heart Rate-Corrected QT Interval (ΔΔQTcI), If a Substantial Heart Rate Effect Was Observed | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcI. | QT/QTc population included all participants who received 1 dose of study drug with measurements at baseline as well as on treatment with at least 1 post-dose time point with a valid ΔQTc value. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | msec | Baseline (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12 and 24 hours post-dose |
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| Secondary | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Changes | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. Number of participants with potentially clinically significant ECG changes were reported. | The safety population included all participants who received 1 dose of study drug. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Count of Participants | Participants | No | Baseline up to Day 33 |
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| Secondary | Number of Participants With Treatment Emergent Changes in T-wave Morphology and U-wave Presence | The cardiodynamic assessment was performed through 12-lead ECG extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. Number of participants with treatment emergent changes in T-wave morphology and U-wave presence were reported. | The safety population included all participants who received 1 dose of study drug. As per planned analysis, data was planned to be reported only for Treatment A and B for this outcome measure. | Posted | Count of Participants | Participants | No | Baseline up to Day 33 |
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| Secondary | Pharmacokinetic (PK): Percentage of AUC0-inf Extrapolated (AUC%Extrap) of Pirtobrutinib | PK: %AUCextrap was defined as percentage extrapolation for AUC0-inf. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of AUC | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Mean Residence Time (MRT) of Pirtobrutinib | PK: MRT was calculated by the area under the first moment curve divided by the area under the concentration time curve. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Apparent Volume of Distribution at the Terminal Phase (Vz/F) of Pirtobrutinib | PK: Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F was calculated as (CL/F)/Lambda Z. Where, CL/F is the apparent total clearance and lambda Z is the apparent terminal elimination rate constant. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib | PK: Tmax was defined as the time to reach maximum observed plasma concentration (Cmax) for pirtobrutinib. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Median | Full Range | hours | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib | PK: t1/2 was defined as the terminal elimination phase half-life for pirtobrutinib. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Maximum Observed Concentration (Cmax) of Pirtobrutinib | PK: Cmax was defined as the maximum plasma concentration for pirtobrutinib. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib | PK: AUC(0-24) was defined as the area under the plasma concentration-time curve from 0 time to 24 hours post-dose. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24 hours post-dose |
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| Secondary | PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib | PK: AUC(0-t) was defined as the area under the plasma concentration-time curve from 0 time to last measurable point for pirtobrutinib. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib | PK: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as (Dose/AUC(0-inf))/F. Where AUC(0-inf) is the area under the plasma concentration-time curve from zero to infinity and F is the bioavailability of the drug. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Pirtobrutinib | PK: AUC(0-inf) was defined as the area under the plasma concentration-time curve from 0 to infinity for pirtobrutinib. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| Secondary | PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib | PK: Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase. | PK population included participants who received 1 dose of pirtobrutinib and have at least 1 quantifiable plasma concentration of pirtobrutinib and have evaluable PK data. Here, 'Overall Number of participants analyzed' signifies individual participants who were evaluable for rate constant evaluation. As per planned analysis, data was planned to be reported only for Treatment A for this outcome measure. | Posted | Number | one per hour (1/h) | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8.5, 12, 24, 48, 72, and 96 hours post-dose |
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| 0 |
| 30 |
| 0 |
| 30 |
| 6 |
| 30 |
| EG001 | Treatment B: 900 mg Pirtobrutinib Matched Placebo | Participants who received a single oral dose of 900 mg pirtobrutinib matched placebo capsules. | 0 | 31 | 0 | 31 | 1 | 31 |
| EG002 | Treatment C: 400 mg Moxifloxacin | Participants who received a single oral dose of 400 mg Moxifloxacin tablet. | 0 | 30 | 0 | 30 | 1 | 30 |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Title | Measurements |
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| Participant 4 |
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