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| ID | Type | Description | Link |
|---|---|---|---|
| RENAL IMPAIRMENT | Other Identifier | Alias Study Number |
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This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.
This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment. Each subject will receive a single oral dose of lorlatinib administered in the fasted state. Subjects with mild, moderate, and severe renal impairment will be enrolled and normal healthy subjects will be enrolled as matched controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild | Experimental | Mild renal impairment |
|
| Moderate | Experimental | Moderate renal impairment |
|
| Severe | Experimental | Severe renal impairment |
|
| Normal | Other | Normal renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | Lorlatinib single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | AUCinf was calculated by AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration; Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | Cmax was observed directly from data. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event did not need to have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Number of participants with both all-causality and treatment-related TEAEs are presented below. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Lorlatinib | AUClast was calculated by linear/Log trapezoidal method. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Time for Cmax (Tmax) of Lorlatinib |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Prism Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018553 | Derived | Lin S, Gong J, Canas GC, Winkle P, Pelletier K, LaBadie RR, Ginman K, Pithavala YK. A Phase I Study to Evaluate the Pharmacokinetics and Safety of Lorlatinib in Adults with Mild, Moderate, and Severe Renal Impairment. Eur J Drug Metab Pharmacokinet. 2022 Mar;47(2):235-245. doi: 10.1007/s13318-021-00747-4. Epub 2022 Jan 11. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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The mild renal impairment participants were recruited first. After lorlatinib was tolerated in at least 3 mild impairment participants, moderate impairment participants were enrolled. After dosing of 3 moderate impairment participants for at least 1 week, the remaining moderate impairment participants and the severe impairment participants were enrolled. The enrollment of normal renal function participants began after all renal impairment participants completed the PK collection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Function | Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| FG001 | Mild Impairment | Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| FG002 | Moderate Impairment | Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| FG003 | Severe Impairment | Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Function | Participants with normal renal function received a 100 mg dose of lorlatinib tablets with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| BG001 | Mild Impairment |
| 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 | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | AUCinf was calculated by AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration; Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
Baseline up to 28 days after last dose of study treatment (approximately 29 days)
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
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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 | Normal Function | Participants with normal renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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 | Jun 22, 2018 | Feb 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2018 | Feb 2, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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| Baseline up to 28 days after last dose of study treatment (approximately 29 days) |
| Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormalities | The hematology, chemistry and urinalysis tests were included in the laboratory examination. Hematology evaluation included hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin concentration and erythrocyte mean corpuscular hemoglobin. Chemistry evaluation included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein, lipase and amylase. Urinalysis evaluation included decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy, ketones, nitrite, leukocyte esterase, urobilinogen, urine bilirubin and bacteria. The lab abnormalities were reported in accordance with the sponsor reporting standards. | Screening, Day -1, Day 2 and Day 6 |
| Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | Vital signs evaluations included supine diastolic blood pressure (DBP), and supine systolic blood pressure (SBP) were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest. Number of participants with vital signs data meeting the categorical summarization criteria is presented. The pre-specified criteria of vital signs data were categorized as follows: SBP (minimum) <90 mmHg, maximum of decrease and increase from baseline for SBP >=30 mmHg; DBP (minimum) <50 mmHg, maximum of decrease and increase from baseline for DBP>=20 mmHg. | Baseline up to 28 days after last dose of study treatment (approximately 29 days) |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), and QT interval corrected for heart rate using Fridericia's formula (QTcF interval). The pre-specified criteria of ESG data were categorized as below. | Screening, Day -1, 0 hours (pre-dose), 1 hour, 2 hours, 4 hours, 24 hours and 120 hours postdose. |
Tmax was observed directly from data as time of first occurrence. |
| 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Terminal Elimination Plasma Half-life (t½) of Lorlatinib | t1/2 was calculated by ln(2)/kel. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Apparent Clearance After Oral Dose (CL/F) of Lorlatinib | CL/F was calculated by Dose/AUCinf. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Apparent Volume of Distribution Following Oral Dose (Vz/F) of Lorlatinib | Vz/F was calculated by Dose/(AUCinf*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Renal Clearance (CLR) of Lorlatinib | CLR was calculated by Ae/AUClast. Ae was cumulative amount of drug recovered unchanged in urine, which was calculated by sum of (urine concentration × sample volume) for each collection interval from 0 to time 120 hours postdose. Sample volume = (urine weight in g/1.020), where 1.020 g/mL is the approximate specific gravity of urine. | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| BG002 | Moderate Impairment | Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| BG003 | Severe Impairment | Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Mild Impairment | Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| OG002 | Moderate Impairment | Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
| OG003 | Severe Impairment | Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | Cmax was observed directly from data. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event did not need to have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Number of participants with both all-causality and treatment-related TEAEs are presented below. | The analysis population included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment (approximately 29 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormalities | The hematology, chemistry and urinalysis tests were included in the laboratory examination. Hematology evaluation included hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin concentration and erythrocyte mean corpuscular hemoglobin. Chemistry evaluation included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein, lipase and amylase. Urinalysis evaluation included decimal logarithm of reciprocal of hydrogen ion activity [pH], glucose, protein, blood, ketones, microscopy, ketones, nitrite, leukocyte esterase, urobilinogen, urine bilirubin and bacteria. The lab abnormalities were reported in accordance with the sponsor reporting standards. | The analysis population included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Screening, Day -1, Day 2 and Day 6 |
|
|
|
| Secondary | Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | Vital signs evaluations included supine diastolic blood pressure (DBP), and supine systolic blood pressure (SBP) were measured with the participant's arm supported at the level of the heart and recorded to the nearest mmHg after approximately 5 minutes of rest. Number of participants with vital signs data meeting the categorical summarization criteria is presented. The pre-specified criteria of vital signs data were categorized as follows: SBP (minimum) <90 mmHg, maximum of decrease and increase from baseline for SBP >=30 mmHg; DBP (minimum) <50 mmHg, maximum of decrease and increase from baseline for DBP>=20 mmHg. | The analysis population included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to 28 days after last dose of study treatment (approximately 29 days) |
|
|
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), and QT interval corrected for heart rate using Fridericia's formula (QTcF interval). The pre-specified criteria of ESG data were categorized as below. | The analysis population included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Screening, Day -1, 0 hours (pre-dose), 1 hour, 2 hours, 4 hours, 24 hours and 120 hours postdose. |
|
|
|
| Other Pre-specified | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Lorlatinib | AUClast was calculated by linear/Log trapezoidal method. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
| Other Pre-specified | Time for Cmax (Tmax) of Lorlatinib | Tmax was observed directly from data as time of first occurrence. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Median | Full Range | hours | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
| Other Pre-specified | Terminal Elimination Plasma Half-life (t½) of Lorlatinib | t1/2 was calculated by ln(2)/kel. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Mean | Standard Deviation | hours | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
| Other Pre-specified | Apparent Clearance After Oral Dose (CL/F) of Lorlatinib | CL/F was calculated by Dose/AUCinf. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
| Other Pre-specified | Apparent Volume of Distribution Following Oral Dose (Vz/F) of Lorlatinib | Vz/F was calculated by Dose/(AUCinf*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
| Other Pre-specified | Renal Clearance (CLR) of Lorlatinib | CLR was calculated by Ae/AUClast. Ae was cumulative amount of drug recovered unchanged in urine, which was calculated by sum of (urine concentration × sample volume) for each collection interval from 0 to time 120 hours postdose. Sample volume = (urine weight in g/1.020), where 1.020 g/mL is the approximate specific gravity of urine. | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Mild Impairment | Participants with mild renal impairment received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | Moderate Impairment | Participants with moderate renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG003 | Severe Impairment | Participants with severe renal function received a 100 mg single oral dose of lorlatinib tablet on day 1 with approximately 240 mL of ambient temperature water at approximately 0800 hours (±3 hours) following an overnight fast of at least 10 hours. | 0 | 5 | 0 | 5 | 1 | 5 |
| Blood pressure increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| ANOVA |
The natural log transformed parameter was used. |
| Slope |
| 88.87 |
| 2-Sided |
| 90 |
| 64.18 |
| 123.06 |
Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference. |
| Other |
| ANOVA | The natural log transformed parameter was used. | Ratio (%) of Adjusted Geometric Means | 92.32 | 2-Sided | 90 | 56.58 | 150.63 | Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference. | Other |
| All-causality SAEs |
|
| Treatment-related AEs |
|
| Treatment-related SAEs |
|
| Supine SBP ≥ 30 mmHg increase |
|
| Supine SBP ≥ 30 mmHg decrease |
|
| Supine DBP < 50 mmHg |
|
| Supine DBP ≥ 20 mmHg increase |
|
| Supine DBP ≥ 20 mmHg decrease |
|
| PR interval ≥ 200 to <240 msec |
|
| PR interval ≥ 240 to <260 msec |
|
| PR interval ≥ 260msec |
|
| QRS interval >120 msec |
|
| QT interval ≥ 500 msec |
|
| QTcF interval ≥ 450 to <480 msec |
|
| QTcF interval ≥ 480 msec |
|
| PR interval change from baseline ≥ 40 to <60 msec |
|
| PR interval change from baseline ≥ 60 to <80 msec |
|
| PR interval change from baseline ≥ 80 msec |
|
| PR interval percent change from baseline > 25% |
|
| QRS interval percent change from baseline ≥ 50% |
|
| QTcF interval change from baseline ≥ 30 to <60 msec |
|
| QTcF interval change from baseline ≥ 60 msec |
|