A Phase 1 interventional study of Brodalumab in Psoriasis, sponsored by Bausch Health Americas, Inc.. Completed at 10 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-10.
Sponsored by Bausch Health Americas, Inc. · Phase 1, Interventional, and Other
This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects with moderate to severe plaque psoriasis.
Approximately 30 subjects will be enrolled into two groups. Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single subcutaneous (SC) dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
open label, all subjects receive brodulamab
Drug: Brodalumab
MDZ 2mg oral (Day 1 and Day 9), Brodalumab 210mg SC (Day 2)
Drug: Brodalumab
Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
Also known as: AMG 827
The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30
Time frame: Day 1 to day 9
The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30
Time frame: Day 1 to Day 9
The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2
Time frame: Day 1 to Day 9
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 21 | 10 |
| Completed | 20 | 10 |
| Not completed | 1 | 0 |
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30
| nanograms per milliliter | Cohort 1 |
|---|---|
| The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab | 11.5 ± 4.59 |
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30
| hr*ng/mL | Cohort 1 |
|---|---|
| The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf) | 41.5 ± 22.1 |
Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2
| hr*ng/mL | Cohort 1 |
|---|---|
| The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration | 39 ± 19.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | — | 0/20 (0%) | 13/20 (65%) |
| Cohort 2 | — | 0/10 (0%) | 5/10 (50%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| Crohn's DiseaseGastrointestinal disorders | 0/20 | 1/10 |
| Injection Site reactionGeneral disorders | 0/20 | 1/10 |
| Abdominal DiscomfortGastrointestinal disorders | 0/20 | 1/10 |
| Abdominal PainGastrointestinal disorders | 0/20 | 1/10 |
| PyrexiaGeneral disorders | 0/20 | 1/10 |
| Muscle StrainMusculoskeletal and connective tissue disorders | 0/20 | 1/10 |
| DysgeusiaNervous system disorders | 2/20 | 0/10 |
| SomnolenceNervous system disorders | 2/20 | 0/10 |
| presyncopeNervous system disorders | 1/20 | 0/10 |
| headacheNervous system disorders | 1/20 | 0/10 |
| Age, Categorical(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 10 | 31 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 41.2 ± 10.9 | 46.8 ± 15.6 | 43 ± 12.6 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 15 | 9 | 24 |
| Male | 6 | 1 | 7 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 16 | 8 | 24 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Bausch Health Americas, Inc.