Healthy VolunteersPhase 1NCT03184168
Single-dose Study of [14C]Lorlatinib (PF-06463922) Metabolism In Healthy Male Volunteers
A Phase 1 study testing [14C]lorlatinib in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
This open-label, radiolabeled, single 100-mg dose study in 6 healthy male volunteers has been designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in plasma; a benzoic acid metabolite (M8)… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]lorlatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to 25 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (no clinically relevant abnormalities) males, 18 to 55 years at the time of screening.
- BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, CV, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding seasonal allergies).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug test.
- History of regular alcohol consumption exceeding 14 drinks/week within 6 months before screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the dose of investigational product (whichever is longer).
- Screening BP ≥ 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of rest. If systolic or diastolic BP is higher at screening, repeat 2 times and use average of 3 BP values.
Show all 19Show fewer
- Screening supine 12 lead ECG QTc interval >450 msec or QRS interval >120 msec, or PR interval > 180 msec. If QTc or QRS exceed, ECG should be repeated 2 more times and the average of the 3 QTc or QRS should be used.
- Subjects with ANY of the following abnormalities in clinical laboratory tests at screening (and confirmed with single repeat): AST or ALT level > 1.0 × ULN; Total bilirubin level > 1.5 × ULN. If history of Gilbert's syndrome, subject would be eligible provided the direct bilirubin level is ≤ ULN.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to study drug dose. Acetaminophen may be used at dosed up to 1 g/day. Limited use of nonRx medications may be permitted following approval by the sponsor. Herbal supplements and hormone replacement therapy must have been discontinued at least 28 days prior to study drug dose.
- Blood donation (excluding plasma) of ~ 1 pint (500 mL) or more within 60 days prior to dosing.
- History of HIV, hepatitis B, or hepatitis C; positive testing for HIV, HepBsAg, HepBcAb, or HCVAb.
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
- History of irregular bowel movements eg, regular episodes of diarrhea or constipation, irritable bowel syndrome or lactose intolerance.
- Enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry (ie, occupational exposure of 5 rem per year).
- Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
- Subjects who have used tobacco within 90 days prior to dosing.
- Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Open-label, Radiolabeled, Single-dose Study To Investigate The Metabolism Of [14c]Lorlatinib (Pf-06463922) In Healthy Male Volunteers
This open-label, radiolabeled, single 100-mg dose study in 6 healthy male volunteers has been designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in plasma; a benzoic acid metabolite (M8) resulting from cleavage of the amide and aromatic ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity. However, due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure, could not be determined. In this current study, the radiolabel will be on the pyrazole ring allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib molecule cleaved during the formation of the M8 metabolite. Since M8 will not be radiolabeled, its concentrations in plasma will be determined using a validated assay.
The sample size of 6 was selected to ensure at least 4 fully evaluable subjects with completed collections of plasma, urine, and fecal samples. This is a standard sample size used for mass-balance/ADME studies which include assessment of metabolic profiling, and is not based on empirical data or hypothesis testing criteria.
Read more
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the following early release criteria is met: 1) recovery in excreta of at least 90% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite will be analyzed using validated assays. Information from this study will complement the metabolic profiling results from study B7461004, will help guide in the assessment of potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib.
Banked biospecimens will be collected for the purpose of conducting research. Collecting biospecimens for exploratory analyses makes it possible to better understand the investigational product's mechanism of action and to seek explanations for differences in, for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the beginning of the study.
Read the detailed description
This open-label, radiolabeled, single 100-mg dose study in approximately 6 healthy male volunteers has been designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in plasma; a benzoic acid metabolite (M8, PF-06895751) resulting from cleavage of the amide and aromatic ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity or ~ 47.3% plasma M8 to lorlatinib AUC percent ratio. However, due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure, could not be determined. In this current study, the radiolabel will be on the pyrazole ring allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib molecule cleaved during the formation of the M8 metabolite. Since the M8 metabolite will not be radiolabeled, its concentrations in plasma will be determined using a validated liquid chromatography tandem mass spectrometric (LC/MS/MS) assay.
The sample size of approximately 6 was selected to ensure at least 4 fully evaluable subjects with completed collections of plasma, urine, and fecal samples. This is a standard sample size used for mass-balance/ADME studies which include assessment of metabolic profiling, and is not based on empirical data or hypothesis testing criteria.
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the early release criteria is met. The early release criteria are: 1) recovery in excreta of at least 90% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite will be analyzed using validated assays. Information from this study will complement the metabolic profiling results from study B7461004, will help guide in the assessment of potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib, and will aid in the understanding of the possible causes for the unexpected findings from a DDI study where a single 100 mg dose of lorlatinib was co-administered with 600 mg rifampin QD (study B7461011).
Banked biospecimens will be collected for the purpose of conducting research; specific uses are described in the Banked Biospecimens section. Comparing the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), protein, and metabolite variation patterns of subjects who respond well and those who respond poorly to treatment may help to better define the most appropriate group of subjects in which to target a given treatment. Collecting biospecimens for exploratory pharmacogenomic/genomic/biomarker analyses and retaining them in the Biospecimen Banking System (BBS) make it possible to better understand the investigational product's mechanism of action and to seek explanations for differences in, for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the beginning of the study.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]lorlatinib
- Keywords
- healthy volunteers, lorlatinib, PF-06463922, ADME, NSCLC, radiolabel, metabolism
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]lorlatinibDrug
Also called [14C]PF-06463922
Extemporaneously compounded oral solution of [14C]lorlatinib (approximately 100 mg/100 µCi)
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | [14C]lorlatinib Receives: Drug: [14C]lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic profiling for lorlatinib will be determined in plasma, urine and fecal samples.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Measured: Assessments will be made up to 14 days post dose
Secondary outcomes (5)
Maximum exposure in plasma will be determined for lorlatinib, M8 metabolite and total radioactivity
Cmax (maximum observed plasma concentration) will be reported directly from each analyte's data
Measured: Assessments will be made up to 14 days postdose
Time of maximum exposure in plasma will be determined for lorlatinib, M8 metabolite and total radioactivity
Tmax (Time of Cmax) will be reported directly from each analyte's data as time of first Cmax occurrence
Measured: Assessments will be made up to 14 days post dose
Exposure up to the last quantifiable concentration will be determined for lorlatinib, M8 metabolite and total radioactivity
AUClast (Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for each analyte
Measured: Assessments will be made up to 14 days post dose
The overall exposure in plasma will be determined for lorlatinib, M8 metabolite and total radioactivity
AUCinf (Area under the plasma concentration time profile from time 0 extrapolated to infinite time) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for each analyte
Measured: Assessments will be made up to 14 days post dose
The terminal elimination half life in plasma will be estimated from plasma profiles over time for lorlatinib, M8 metabolite and total radioactivity
t1/2 (apparent terminal elimination half life) will be estimated for each analyte from the terminal portion of its plasma concentration versus time plot
Measured: Assessments will be made up to 14 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start5 Jul 2017
- Primary completion7 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, radiolabeled, single-dose study of an oral solution of \[14C\]lorlatinib (100 mg/100 µCi) in 6 healthy male volunteers. Confinement from Day -1 through Day 14 (or until 1 of 2 early release criteria is met). No returns; one follow-up phone call (at 28 to 35 days post dose).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184168
- Sponsor's protocol ID
- B7461017
- Other IDs
- 14C ADME
- Status last verified
- Sep 2017
- First submitted
- 17 May 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label, Radiolabeled, Single-dose Study To Investigate The Metabolism Of [14c]Lorlatinib (Pf-06463922) In Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03184168
- Acronym / sponsor ID
- B7461017
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers, lorlatinib, PF-06463922, ADME, NSCLC, radiolabel, metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 7 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, radiolabeled, single 100-mg dose study in 6 healthy male volunteers has been designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in plasma; a benzoic acid metabolite (M8) resulting from cleavage of the amide and aromatic ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity. However, due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure, could not be determined. In this current study, the radiolabel will be on the pyrazole ring allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib molecule cleaved during the formation of the M8 metabolite. Since M8 will not be radiolabeled, its concentrations in plasma will be determined using a validated assay.
The sample size of 6 was selected to ensure at least 4 fully evaluable subjects with completed collections of plasma, urine, and fecal samples. This is a standard sample size used for mass-balance/ADME studies which include assessment of metabolic profiling, and is not based on empirical data or hypothesis testing criteria.
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the following early release criteria is met: 1) recovery in excreta of at least 90% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite will be analyzed using validated assays. Information from this study will complement the metabolic profiling results from study B7461004, will help guide in the assessment of potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib.
Banked biospecimens will be collected for the purpose of conducting research. Collecting biospecimens for exploratory analyses makes it possible to better understand the investigational product's mechanism of action and to seek explanations for differences in, for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the beginning of the study.
Detailed description
This open-label, radiolabeled, single 100-mg dose study in approximately 6 healthy male volunteers has been designed to further the understanding of human metabolism of lorlatinib. A prior radiolabel study using [14C]lorlatinib (study B7461004) identified an unexpected major metabolite in plasma; a benzoic acid metabolite (M8, PF-06895751) resulting from cleavage of the amide and aromatic ether bonds of lorlatinib, accounting for 21.0% of the circulating radioactivity or ~ 47.3% plasma M8 to lorlatinib AUC percent ratio. However, due to the position of the 14C radiolabel on the carbonyl carbon, the metabolic fate of the larger fragment of lorlatinib resulting from this cleavage, the pyrido-pyrazole substructure, could not be determined. In this current study, the radiolabel will be on the pyrazole ring allowing for monitoring the metabolic fate of the pyrido-pyrazole part of the lorlatinib molecule cleaved during the formation of the M8 metabolite. Since the M8 metabolite will not be radiolabeled, its concentrations in plasma will be determined using a validated liquid chromatography tandem mass spectrometric (LC/MS/MS) assay.
The sample size of approximately 6 was selected to ensure at least 4 fully evaluable subjects with completed collections of plasma, urine, and fecal samples. This is a standard sample size used for mass-balance/ADME studies which include assessment of metabolic profiling, and is not based on empirical data or hypothesis testing criteria.
Metabolic profiling of radiolabeled components will be performed on pooled plasma samples as well as on cumulative urine and feces excreted until Day 14 postdose or until one of the early release criteria is met. The early release criteria are: 1) recovery in excreta of at least 90% of administered radioactivity, or 2) less than 1% of administered radioactivity being recovered in excreta from two consecutive days (ie, total for urine + feces should be <1% on 2 consecutive days). Plasma concentrations of both lorlatinib and its unlabeled M8 metabolite will be analyzed using validated assays. Information from this study will complement the metabolic profiling results from study B7461004, will help guide in the assessment of potential drug-drug interactions (DDIs) and the need for other DDI studies with lorlatinib, and will aid in the understanding of the possible causes for the unexpected findings from a DDI study where a single 100 mg dose of lorlatinib was co-administered with 600 mg rifampin QD (study B7461011).
Banked biospecimens will be collected for the purpose of conducting research; specific uses are described in the Banked Biospecimens section. Comparing the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), protein, and metabolite variation patterns of subjects who respond well and those who respond poorly to treatment may help to better define the most appropriate group of subjects in which to target a given treatment. Collecting biospecimens for exploratory pharmacogenomic/genomic/biomarker analyses and retaining them in the Biospecimen Banking System (BBS) make it possible to better understand the investigational product's mechanism of action and to seek explanations for differences in, for example, exposure, tolerability, safety, and/or efficacy not anticipated prior to the beginning of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, radiolabeled, single-dose study of an oral solution of [14C]lorlatinib (100 mg/100 µCi) in 6 healthy male volunteers. Confinement from Day -1 through Day 14 (or until 1 of 2 early release criteria is met). No returns; one follow-up phone call (at 28 to 35 days post dose).
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: [14C]lorlatinib[14C]lorlatinib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy (no clinically relevant abnormalities) males, 18 to 55 years at the time of screening.
- BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (19 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, CV, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding seasonal allergies).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug test.
- History of regular alcohol consumption exceeding 14 drinks/week within 6 months before screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the dose of investigational product (whichever is longer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]lorlatinibAlso: [14C]PF-06463922Extemporaneously compounded oral solution of [14C]lorlatinib (approximately 100 mg/100 µCi) | Drug | treatment |
Primary outcome
Metabolic profiling for lorlatinib will be determined in plasma, urine and fecal samples.
Time frame: Assessments will be made up to 14 days post dose
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
5 secondary outcomes
Maximum exposure in plasma will be determined for lorlatinib, M8 metabolite and total radioactivity
Time frame: Assessments will be made up to 14 days postdose
Time of maximum exposure in plasma will be determined for lorlatinib, M8 metabolite and total radioactivity
Time frame: Assessments will be made up to 14 days post dose
Exposure up to the last quantifiable concentration will be determined for lorlatinib, M8 metabolite and total radioactivity
Time frame: Assessments will be made up to 14 days post dose
The overall exposure in plasma will be determined for lorlatinib, M8 metabolite and total radioactivity
Time frame: Assessments will be made up to 14 days post dose
The terminal elimination half life in plasma will be estimated from plasma profiles over time for lorlatinib, M8 metabolite and total radioactivity
Time frame: Assessments will be made up to 14 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]lorlatinib in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic profiling for lorlatinib will be determined in plasma, urine and fecal samples. (time frame: Assessments will be made up to 14 days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.