Trial · NCT03542305
Lorlatinib Renal Impairment Study
NCT03542305, Phase 1, Completed, Pfizer; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lorlatinib Renal Impairment Study. Trials, record NCT03542305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03542305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lorlatinib Renal Impairment Study
- NCT number
- NCT03542305
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Renal Impairment
- Interventions
- Lorlatinib
- First posted
- 2018-05-31
- Last updated
- 2021-02-21
- Results first posted
- 2021-02-21
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | 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. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | Cmax was observed directly from data. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 28 days after last dose of study treatment (approximately 29 days) | 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. |
| Secondary | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormalities | Screening, Day -1, Day 2 and Day 6 | 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. |
| Secondary | Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | Baseline up to 28 days after last dose of study treatment (approximately 29 days) | 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. |
| Secondary | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | Screening, Day -1, 0 hours (pre-dose), 1 hour, 2 hours, 4 hours, 24 hours and 120 hours postdose. | 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. |
| Other | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | AUClast was calculated by linear/Log trapezoidal method. |
| Other | Time for Cmax (Tmax) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | Tmax was observed directly from data as time of first occurrence. |
| Other | Terminal Elimination Plasma Half-life (t½) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | t1/2 was calculated by ln(2)/kel. |
| Other | Apparent Clearance After Oral Dose (CL/F) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | CL/F was calculated by Dose/AUCinf. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | ng*hr/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 28 days after last dose of study treatment (approximately 29 days) | The analysis population included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormalities | Screening, Day -1, Day 2 and Day 6 | The analysis population included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria | Baseline up to 28 days after last dose of study treatment (approximately 29 days) | The analysis population included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria | Screening, Day -1, 0 hours (pre-dose), 1 hour, 2 hours, 4 hours, 24 hours and 120 hours postdose. | The analysis population included all participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | ng*hr/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Time for Cmax (Tmax) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | hours | MEDIAN |
| OTHER_PRE_SPECIFIED | Terminal Elimination Plasma Half-life (t½) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | hours | MEAN |
| OTHER_PRE_SPECIFIED | Apparent Clearance After Oral Dose (CL/F) of Lorlatinib | 0 (pre-dose), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose | The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest. | L/hr | GEOMETRIC_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group136
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | Normal Function | 8329 | Geometric Coefficient of Variation 33 | ng*hr/mL | |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | Mild Impairment | 8683 | Geometric Coefficient of Variation 29 | ng*hr/mL | |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | Moderate Impairment | 9890 | Geometric Coefficient of Variation 27 | ng*hr/mL | |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Lorlatinib | Severe Impairment | 11760 | Geometric Coefficient of Variation 37 | ng*hr/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | Normal Function | 546.8 | Geometric Coefficient of Variation 48 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | Mild Impairment | 549.7 | Geometric Coefficient of Variation 52 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | Moderate Impairment | 485.9 | Geometric Coefficient of Variation 24 | ng/mL | |
| Maximum Observed Plasma Concentration (Cmax) of Lorlatinib | Severe Impairment | 504.8 | Geometric Coefficient of Variation 50 | ng/mL | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Normal Function | All-causality AEs | 5 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mild Impairment | All-causality AEs | 2 | Participants |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Normal Function | 8 | |
| Overall Study | STARTED | Mild Impairment | 8 | |
| Overall Study | STARTED | Moderate Impairment | 8 | |
| Overall Study | STARTED | Severe Impairment | 5 | |
| Overall Study | COMPLETED | Normal Function | 8 | |
| Overall Study | COMPLETED | Mild Impairment | 8 | |
| Overall Study | COMPLETED | Moderate Impairment | 8 | |
| Overall Study | COMPLETED | Severe Impairment | 5 | |
| Overall Study | NOT COMPLETED | Normal Function | 0 | |
| Overall Study | NOT COMPLETED | Mild Impairment | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Normal Function | 1 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Mild Impairment | 0 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Moderate Impairment | 1 | 8 | |
| other | Diarrhoea | Gastrointestinal disorders | Severe Impairment | 0 | 5 | |
| other | Blood pressure increased | Investigations | Normal Function | 0 | 8 | |
| other | Blood pressure increased | Investigations | Mild Impairment | 1 | 8 | |
| other | Blood pressure increased | Investigations | Moderate Impairment | 0 | 8 | |
| other | Blood pressure increased | Investigations | Severe Impairment | 1 | 5 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Normal Function | 0 | 8 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Mild Impairment | 1 | 8 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Normal Function | 0 | 8 |
| Total, all-cause mortality | Mild Impairment | 0 | 8 |
| Total, all-cause mortality | Moderate Impairment | 0 | 8 |
| Total, all-cause mortality | Severe Impairment | 0 | 5 |
| Total, other adverse events | Normal Function | 5 | 8 |
| Total, other adverse events | Mild Impairment | 2 | 8 |
| Total, other adverse events | Moderate Impairment | 4 | 8 |
| Total, other adverse events | Severe Impairment | 1 | 5 |
| Total, serious adverse events | Normal Function | 0 | 8 |
| Total, serious adverse events | Mild Impairment | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35018553 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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