Trial · NCT03401671
Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
NCT03401671, Phase 1, Completed, Shire; results first posted 2019-07-29
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects. Trials, record NCT03401671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03401671
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
- NCT number
- NCT03401671
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Shire
- Conditions
- Healthy Volunteers
- Interventions
- Lanadelumab
- First posted
- 2018-01-17
- Last updated
- 2021-06-03
- Results first posted
- 2019-07-29
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Cmax is the maximum observed plasma concentration of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Tmax of Lanadelumab was presented. |
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | AUC(0-last) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | AUC(0-infinity) of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Terminal Elimination Rate Constant (Lambda z) for Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Lambda z of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Terminal Half-life (t12) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | t1/2 of Lanadelumab was presented. |
| Primary | Apparent Clearance (CL/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | CL/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Apparent Volume of Distribution (Vz/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Vz/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Body-weight adjusted AUC(0-last) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
| Primary | Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Body-weight adjusted AUC(0-infinity) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | microgram per milliliter (ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day | MEDIAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*microgram per milliliter(day*ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*microgram per milliliter(day* ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Rate Constant (Lambda z) for Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | per day | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-life (t12) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day | MEDIAN |
| PRIMARY | Apparent Clearance (CL/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | liter per day | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution (Vz/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | liter | GEOMETRIC_MEAN |
| PRIMARY | Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*ug/mL/kg | GEOMETRIC_MEAN |
| PRIMARY | Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*ug/mL/kg | GEOMETRIC_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Lanadelumab | Japanese | 21.91 | Geometric Coefficient of Variation 38 | microgram per milliliter (ug/mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Lanadelumab | Non-Hispanic Caucasians | 21.42 | Geometric Coefficient of Variation 25 | microgram per milliliter (ug/mL) | |
| Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab | Japanese | 5.67 | Full Range 2.00 to 6.11 | day | |
| Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab | Non-Hispanic Caucasians | 5.00 | Full Range 3.00 to 13.00 | day | |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Japanese | 510.6 | Geometric Coefficient of Variation 30 | day*microgram per milliliter(day*ug/mL) | |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Non-Hispanic Caucasians | 547.6 | Geometric Coefficient of Variation 20 | day*microgram per milliliter(day*ug/mL) | |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab | Japanese | 515.0 | Geometric Coefficient of Variation 30 | day*microgram per milliliter(day* ug/mL) | |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab | Non-Hispanic Caucasians | 552.7 | Geometric Coefficient of Variation 20 | day*microgram per milliliter(day* ug/mL) | |
| Terminal Elimination Rate Constant (Lambda z) for Lanadelumab | Japanese | 0.04470 | Geometric Coefficient of Variation 9 | per day | |
| Terminal Elimination Rate Constant (Lambda z) for Lanadelumab | Non-Hispanic Caucasians | 0.04385 | Geometric Coefficient of Variation 11 | per day |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Japanese | 16 | |
| Overall Study | STARTED | Non-Hispanic Caucasians | 16 | |
| Overall Study | COMPLETED | Japanese | 16 | |
| Overall Study | COMPLETED | Non-Hispanic Caucasians | 16 | |
| Overall Study | NOT COMPLETED | Japanese | 0 | |
| Overall Study | NOT COMPLETED | Non-Hispanic Caucasians | 0 |
Source ClinicalTrials.gov
Adverse events48
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Japanese | 1 | 16 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Non-Hispanic Caucasians | 0 | 16 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Japanese | 0 | 16 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Non-Hispanic Caucasians | 2 | 16 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Japanese | 1 | 16 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Non-Hispanic Caucasians | 0 | 16 | 0 |
| other | Constipation | Gastrointestinal disorders | Japanese | 1 | 16 | 1 |
| other | Constipation | Gastrointestinal disorders | Non-Hispanic Caucasians | 0 | 16 | 0 |
| other | Nausea | Gastrointestinal disorders | Japanese | 0 | 16 | 0 |
| other | Nausea | Gastrointestinal disorders | Non-Hispanic Caucasians | 2 | 16 | 2 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Japanese | 0 | 16 |
| Total, all-cause mortality | Non-Hispanic Caucasians | 0 | 16 |
| Total, other adverse events | Japanese | 7 | 16 |
| Total, other adverse events | Non-Hispanic Caucasians | 9 | 16 |
| Total, serious adverse events | Japanese | 0 | 16 |
| Total, serious adverse events | Non-Hispanic Caucasians | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Japanese vs Non-Hispanic Caucasians: Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event | Trial comparisons |
| Japanese vs Non-Hispanic Caucasians: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event | Trial comparisons |
| Japanese vs Non-Hispanic Caucasians: deaths from any cause | Trial comparisons |
| Japanese vs Non-Hispanic Caucasians: Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event | Trial comparisons |
| Japanese vs Non-Hispanic Caucasians: serious adverse events | Trial comparisons |
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03401671
GET https://conductscience.org/api/trials/v1/NCT03401671/results?page=2