Trial · NCT03918239
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
NCT03918239, Phase 1, Completed, Shire; results first posted 2020-12-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants. Trials, record NCT03918239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03918239
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
- NCT number
- NCT03918239
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 190 participants, actual
- Lead sponsor
- Shire
- Conditions
- Healthy Volunteers
- Interventions
- SHP643
- First posted
- 2019-04-17
- Last updated
- 2020-12-08
- Results first posted
- 2020-12-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post dose | AUC(0-last) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Primary | Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | AUC(0-infinity) of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Primary | Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Cmax is the maximum observed plasma concentration of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Primary | Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Tmax of of SHP643 in plasma was reported. |
| Primary | Terminal Half-Life (T1/2) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | t1/2 of of SHP643 in plasma was reported. |
| Primary | Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | CL/F of of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Primary | Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Vdz/F of SHP643 in plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Primary | Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | Lambda z of SHP643 in Plasma was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET]) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the investigational product (IP) or medicinal product. A treatment-emergent AE (TEAE) was defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the IP or medicinal product. |
| Secondary | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Day 1, 14, 28, 56 and 112 (End of Study/Early Termination [EOS/ET]) | Plasma samples were analyzed for presence of antidrug antibodies to SHP643. Participants who developed positive results for SHP643 antibodies were reported. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post dose | Pharmacokinetic (PK) set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | 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 SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | day*μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | microgram per milliliter (ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PPK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | day | MEDIAN |
| PRIMARY | Terminal Half-Life (T1/2) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | day | MEDIAN |
| PRIMARY | Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | liter per day (L/day) | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution Associated With the Terminal Slope Following Extravascular Administration Divided by the Fraction of Dose Absorbed (Vdz/F) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Liters (L) | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Rate Constant (Lambda z) of SHP643 in Plasma | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016, 2664 hours post-dose | PK set was defined as all randomized participants who received the complete dose of SHP643 and had sufficient data to calculate at least one primary PK endpoint. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | one per day (1/day) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to Day 112 (End of Study/Early Termination [EOS/ET]) | Safety analysis set consisted of all randomized participants who received the dose of SHP643. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Developed Positive Antidrug Antibodies to SHP643 at Specified Time Points | Day 1, 14, 28, 56 and 112 (End of Study/Early Termination [EOS/ET]) | Safety analysis set consisted of all randomized participants who received the dose of SHP643. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | SHP643 Prefilled Syringe (PFS) | 348.9 | Geometric Coefficient of Variation 33.4 | day*microgram per milliliter (day*ug/mL) | |
| Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of SHP643 in Plasma | SHP643 Autoinjector (AI) | 376.5 | Geometric Coefficient of Variation 41.3 | day*microgram per milliliter (day*ug/mL) | |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma | SHP643 Prefilled Syringe (PFS) | 352.5 | Geometric Coefficient of Variation 32.9 | day*μg/mL | |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-Inf) of SHP643 in Plasma | SHP643 Autoinjector (AI) | 380.3 | Geometric Coefficient of Variation 40.8 | day*μg/mL | |
| Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | SHP643 Prefilled Syringe (PFS) | 15.86 | Geometric Coefficient of Variation 40.6 | microgram per milliliter (ug/mL) | |
| Maximum Observed Plasma Drug Concentration (Cmax) of SHP643 in Plasma | SHP643 Autoinjector (AI) | 18.35 | Geometric Coefficient of Variation 48.0 | microgram per milliliter (ug/mL) | |
| Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | SHP643 Prefilled Syringe (PFS) | 4.00 | Full Range 3.00 to 19.97 | day | |
| Minimum Time to Reach (Tmax) in Maximum Observed Plasma Drug Concentration of SHP643 in Plasma | SHP643 Autoinjector (AI) | 4.00 | Full Range 2.00 to 6.92 | day | |
| Terminal Half-Life (T1/2) of SHP643 in Plasma | SHP643 Prefilled Syringe (PFS) | 13.76 | Full Range 9.70 to 20.5 | day | |
| Terminal Half-Life (T1/2) of SHP643 in Plasma | SHP643 Autoinjector (AI) | 13.20 | Full Range 8.21 to 40.1 | day |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHP643 Prefilled Syringe (PFS) | 94 | |
| Overall Study | STARTED | SHP643 Autoinjector (AI) | 96 | |
| Overall Study | COMPLETED | SHP643 Prefilled Syringe (PFS) | 84 | |
| Overall Study | COMPLETED | SHP643 Autoinjector (AI) | 89 | |
| Overall Study | NOT COMPLETED | SHP643 Prefilled Syringe (PFS) | 10 | |
| Overall Study | NOT COMPLETED | SHP643 Autoinjector (AI) | 7 |
Source ClinicalTrials.gov
Adverse events12
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 | Injection site haemorrhage | General disorders | SHP643 Prefilled Syringe (PFS) | 0 | 94 | 0 |
| other | Injection site haemorrhage | General disorders | SHP643 Autoinjector (AI) | 9 | 96 | 9 |
| serious | Anaemia | Blood and lymphatic system disorders | SHP643 Prefilled Syringe (PFS) | 0 | 94 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | SHP643 Autoinjector (AI) | 1 | 96 | 1 |
| serious | Appendicitis | Infections and infestations | SHP643 Prefilled Syringe (PFS) | 1 | 94 | 1 |
| serious | Appendicitis | Infections and infestations | SHP643 Autoinjector (AI) | 0 | 96 | 0 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | SHP643 Prefilled Syringe (PFS) | 0 | 94 | 0 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | SHP643 Autoinjector (AI) | 1 | 96 | 1 |
| serious | Nephrolithiasis | Renal and urinary disorders | SHP643 Prefilled Syringe (PFS) | 0 | 94 | 0 |
| serious | Nephrolithiasis | Renal and urinary disorders | SHP643 Autoinjector (AI) | 1 | 96 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHP643 Prefilled Syringe (PFS) | 0 | 94 |
| Total, all-cause mortality | SHP643 Autoinjector (AI) | 0 | 96 |
| Total, other adverse events | SHP643 Prefilled Syringe (PFS) | 0 | 94 |
| Total, other adverse events | SHP643 Autoinjector (AI) | 9 | 96 |
| Total, serious adverse events | SHP643 Prefilled Syringe (PFS) | 2 | 94 |
| Total, serious adverse events | SHP643 Autoinjector (AI) | 2 | 96 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SHP643 Prefilled Syringe (PFS) vs SHP643 Autoinjector (AI): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| SHP643 Prefilled Syringe (PFS) vs SHP643 Autoinjector (AI): deaths from any cause | Trial comparisons |
| SHP643 Prefilled Syringe (PFS) vs SHP643 Autoinjector (AI): 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/NCT03918239
GET https://conductscience.org/api/trials/v1/NCT03918239/results?page=2