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| ID | Type | Description | Link |
|---|---|---|---|
| J2N-OX-JZNT | 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 evaluate the effect of Pirtobrutinib (LOXO-305) on multiple oral doses of digoxin (P-gp substrate) when administered as single and multiple doses by collecting the blood samples and conducting the blood tests to measure how much digoxin is in the bloodstream and how the body handles and eliminates it in healthy participants. The study will also evaluate the safety and tolerability of Pirtobrutinib. Participants will stay in this study for up to 58 days, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin + Pirtobrutinib | Experimental | Participants received oral dose of
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | Administered Orally. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of Digoxin in Plasma | PK: AUC[0-t] of Digoxin was reported. | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Area Under the Concentration During a Dosing Interval (AUC [Tau]) of Digoxin in Plasma | PK: AUC [tau] of Digoxin was reported. | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Apparent Systemic Clearance (CL/F) of Digoxin in Plasma | PK: CL/F of Digoxin in plasma was reported. | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Maximum Observed Plasma Concentration (Cmax) of Digoxin in Plasma | PK: Cmax of Digoxin was reported. | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Digoxin in Plasma | PK: Tmax of Digoxin was reported. | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
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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 | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Digoxin + Pirtobrutinib | Participants received oral dose of
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Digoxin + Pirtobrutinib | Participants received oral dose of
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of Digoxin in Plasma | PK: AUC[0-t] of Digoxin was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h*ng/mL) | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
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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 | 0.25 mg Digoxin |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual impairment | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | 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 | Feb 12, 2021 | Oct 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2021 | Oct 14, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | Administered Orally. |
|
| PK: Mean Residence Time (MRT) of Digoxin in Plasma | PK: MRT of Digoxin was reported. | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Cumulative Amount of Drug Excreted Unchanged in Urine (Ae) of Digoxin | PK: Ae of Digoxin in urine was reported. The urine sampling time points from pre-dose through 24 hours post-dose were used to assess this outcome. | Day 7 and Day 16: Predose, 6, 12, 24 hours post dose |
| PK: Fraction of Digoxin Excreted Unchanged in Urine (Fe) Expressed as Percentage of Dose Excreted | PK: Fe of Digoxin was reported. The urine sampling time points from pre-dose through 24 hours post-dose were used to assess this outcome. | Day 7 and Day 16: Predose, 6, 12, 24 hours post dose |
| PK: Renal Clearance (CLr) of Digoxin in Plasma | PK: CLr of Digoxin in plasma was reported. | Day 7: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Area Under the Concentration From Hour 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib in Plasma | PK: AUC[0-t] of Pirtobrutinib was reported. | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Area Under the Concentration During a Dosing Interval (AUCtau) of Pirtobrutinib in Plasma | PK: AUCtau of Pirtobrutinib was reported. | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib in Plasma | PK: CL/F of Pirtobrutinib in plasma was reported. | Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib in Plasma | PK: Cmax of Pirtobrutinib was reported. | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib in Plasma | PK: Tmax of Pirtobrutinib was reported. | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| PK: Mean Residence Time (MRT) of Pirtobrutinib in Plasma | PK: MRT of Pirtobrutinib was reported. | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Primary | PK: Area Under the Concentration During a Dosing Interval (AUC [Tau]) of Digoxin in Plasma | PK: AUC [tau] of Digoxin was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
|
|
| Primary | PK: Apparent Systemic Clearance (CL/F) of Digoxin in Plasma | PK: CL/F of Digoxin in plasma was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter per hour(L/h) | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
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| Primary | PK: Maximum Observed Plasma Concentration (Cmax) of Digoxin in Plasma | PK: Cmax of Digoxin was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
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| Primary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Digoxin in Plasma | PK: Tmax of Digoxin was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Median | Full Range | hour | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
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| Primary | PK: Mean Residence Time (MRT) of Digoxin in Plasma | PK: MRT of Digoxin was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
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| Primary | PK: Cumulative Amount of Drug Excreted Unchanged in Urine (Ae) of Digoxin | PK: Ae of Digoxin in urine was reported. The urine sampling time points from pre-dose through 24 hours post-dose were used to assess this outcome. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg | Day 7 and Day 16: Predose, 6, 12, 24 hours post dose |
|
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| Primary | PK: Fraction of Digoxin Excreted Unchanged in Urine (Fe) Expressed as Percentage of Dose Excreted | PK: Fe of Digoxin was reported. The urine sampling time points from pre-dose through 24 hours post-dose were used to assess this outcome. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of dose excreted in urine | Day 7 and Day 16: Predose, 6, 12, 24 hours post dose |
|
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| Primary | PK: Renal Clearance (CLr) of Digoxin in Plasma | PK: CLr of Digoxin in plasma was reported. | All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 7: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
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| Primary | PK: Area Under the Concentration From Hour 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib in Plasma | PK: AUC[0-t] of Pirtobrutinib was reported. | All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
|
|
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| Primary | PK: Area Under the Concentration During a Dosing Interval (AUCtau) of Pirtobrutinib in Plasma | PK: AUCtau of Pirtobrutinib was reported. | All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
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| Primary | PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib in Plasma | PK: CL/F of Pirtobrutinib in plasma was reported. | All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
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| Primary | PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib in Plasma | PK: Cmax of Pirtobrutinib was reported. | All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
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| Primary | PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib in Plasma | PK: Tmax of Pirtobrutinib was reported. | All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Median | Full Range | hours | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
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| Primary | PK: Mean Residence Time (MRT) of Pirtobrutinib in Plasma | PK: MRT of Pirtobrutinib was reported. | All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose |
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| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | 200 mg Pirtobrutinib + 0.25 mg Digoxin |
| 0 | 16 | 0 | 16 | 1 | 16 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site injury | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Medical device site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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Not provided
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Day 16 |
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| Day 16 |
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| Day 16 |
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| Day 16 |
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| Day 16 |
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