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Trial Outcomes & Findings for Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects (NCT NCT01937260)

NCT ID: NCT01937260

Last Updated: 2017-04-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

Day 1 to day 9

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure
Cohort 1
Midazolam (MDZ) 2mg Oral (Day 1 and Day 9) Brodalumab 210 mg SC (Day 2)
Cohort 2
Brodalumab 140 mg SC (Day 1)
Overall Study
STARTED
21
10
Overall Study
COMPLETED
20
10
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1
n=21 Participants
Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
Cohort 2
n=10 Participants
Brodalumab 140mg SC (Day1)
Total
n=31 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
n=5 Participants
10 Participants
n=7 Participants
31 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
41.2 years
STANDARD_DEVIATION 10.9 • n=5 Participants
46.8 years
STANDARD_DEVIATION 15.6 • n=7 Participants
43 years
STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
9 Participants
n=7 Participants
24 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
1 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
16 Participants
n=5 Participants
8 Participants
n=7 Participants
24 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to day 9

Population: Analysis population is now 20 subjects after 1 subject was discontinued by sponsor decision

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=20 Participants
Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab
11.5 nanograms per milliliter
Standard Deviation 4.59

PRIMARY outcome

Timeframe: Day 1 to Day 9

Population: 20 subjects analyzed after the discontinuation of 1 subject by sponsor decision

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=20 Participants
Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)
41.5 hr*ng/mL
Standard Deviation 22.1

PRIMARY outcome

Timeframe: Day 1 to Day 9

Population: 20 subjects are now analyzed after the discontinuation of 1 subject by sponsor decision

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

Outcome measures

Outcome measures
Measure
Cohort 1
n=20 Participants
Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
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 hr*ng/mL
Standard Deviation 19.2

Adverse Events

Cohort 1

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Cohort 1
n=20 participants at risk
Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
Cohort 2
n=10 participants at risk
Brodalumab 140mg SC (Day1)
Gastrointestinal disorders
Crohn's Disease
0.00%
0/20
10.0%
1/10
General disorders
Injection Site reaction
0.00%
0/20
10.0%
1/10
Gastrointestinal disorders
Abdominal Discomfort
0.00%
0/20
10.0%
1/10
Gastrointestinal disorders
Abdominal Pain
0.00%
0/20
10.0%
1/10
General disorders
Pyrexia
0.00%
0/20
10.0%
1/10
Musculoskeletal and connective tissue disorders
Muscle Strain
0.00%
0/20
10.0%
1/10
Nervous system disorders
Dysgeusia
10.0%
2/20
0.00%
0/10
Nervous system disorders
Somnolence
10.0%
2/20
0.00%
0/10
Nervous system disorders
presyncope
5.0%
1/20
0.00%
0/10
Nervous system disorders
headache
5.0%
1/20
0.00%
0/10
General disorders
Catheter Site Pain
5.0%
1/20
0.00%
0/10
General disorders
Fatigue
5.0%
1/20
0.00%
0/10
General disorders
Infected Bites
5.0%
1/20
0.00%
0/10
General disorders
Upper Respiratory Tract Infection
5.0%
1/20
0.00%
0/10
Blood and lymphatic system disorders
Anaemia
5.0%
1/20
0.00%
0/10
Cardiac disorders
Palpatations
5.0%
1/20
0.00%
0/10
Ear and labyrinth disorders
Ear Congestion
5.0%
1/20
0.00%
0/10

Additional Information

Director of Clinical Trials

Valeant Pharmaceuticals

Phone: 908

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER