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A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03161405
Recruitment Status : Completed
First Posted : May 19, 2017
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy Participants
Interventions Drug: TAK-906 Maleate
Drug: Itraconazole
Enrollment 12
Recruitment Details Participants took part in the study at 1 investigative site in the United States from 05 June 2017 to 10 July 2017.
Pre-assignment Details Healthy participants were enrolled in single sequence 2-period crossover study to receive TAK-906 maleate 25 milligram (mg) in First Intervention Period followed by Itraconazole 200 mg along with TAK-906 maleate 25 mg in Second Intervention Period.
Arm/Group Title TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg
Hide Arm/Group Description TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
Period Title: First Intervention Period (3 Days)
Started 12
Completed 12
Not Completed 0
Period Title: Washout Period (at Least 4 Days)
Started 12
Completed 12
Not Completed 0
Period Title: Second Intervention Period (6 Days)
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Positive urine drug screen             1
Arm/Group Title TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg
Hide Arm/Group Description TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
The safety set included all enrolled participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
32.3  (7.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
0
   0.0%
Male
12
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Hispanic or Latino
1
   8.3%
Not Hispanic or Latino
11
  91.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
  66.7%
White
4
  33.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 12 participants
85.4  (10.59)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 12 participants
180.8  (6.79)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 12 participants
26.2  (2.52)
1.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for TAK-906
Hide Description [Not Specified]
Time Frame TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.
Arm/Group Title TAK-906 Maleate 25 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Hide Arm/Group Description:
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
Overall Number of Participants Analyzed 12 11
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
9.532  (4.6337) 17.999  (4.8780)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-906 Maleate 25 mg, Itraconazole 200 mg + TAK-906 Maleate 25 mg
Comments A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 1.9827
Confidence Interval (2-Sided) 90%
1.6446 to 2.3904
Estimation Comments [Not Specified]
2.Primary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
Hide Description [Not Specified]
Time Frame TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.
Arm/Group Title TAK-906 Maleate 25 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Hide Arm/Group Description:
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
Overall Number of Participants Analyzed 12 11
Geometric Mean (Standard Deviation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
24.10  (8.173) 30.73  (8.521)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-906 Maleate 25 mg, Itraconazole 200 mg + TAK-906 Maleate 25 mg
Comments A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 1.2914
Confidence Interval (2-Sided) 90%
1.1199 to 1.4891
Estimation Comments [Not Specified]
3.Primary Outcome
Title AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
Hide Description [Not Specified]
Time Frame TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration. PK analysis set where Day 1 and 4 assessments were available.
Arm/Group Title TAK-906 Maleate 25 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Hide Arm/Group Description:
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
Overall Number of Participants Analyzed 12 11
Geometric Mean (Standard Deviation)
Unit of Measure: h*ng/mL
24.41  (8.136) 31.45  (8.995)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TAK-906 Maleate 25 mg, Itraconazole 200 mg + TAK-906 Maleate 25 mg
Comments A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric mean ratio
Estimated Value 1.2783
Confidence Interval (2-Sided) 90%
1.0965 to 1.4904
Estimation Comments [Not Specified]
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title TAK-906 Maleate 25 mg Itraconazole 200 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Hide Arm/Group Description TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period. Itraconazole 200 mg, solution, orally, once daily on Days 1 to 3 of Second Intervention Period. Itraconazole 200 mg, solution, orally, once daily on Days 4 and 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
All-Cause Mortality
TAK-906 Maleate 25 mg Itraconazole 200 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
TAK-906 Maleate 25 mg Itraconazole 200 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAK-906 Maleate 25 mg Itraconazole 200 mg Itraconazole 200 mg + TAK-906 Maleate 25 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   1/11 (9.09%)   1/11 (9.09%) 
Gastrointestinal disorders       
Constipation  1  0/12 (0.00%)  0/11 (0.00%)  1/11 (9.09%) 
Skin and subcutaneous tissue disorders       
Swelling face  1  0/12 (0.00%)  1/11 (9.09%)  0/11 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT03161405     History of Changes
Other Study ID Numbers: TAK-906-1003
U1111-1192-7802 ( Registry Identifier: WHO )
First Submitted: May 18, 2017
First Posted: May 19, 2017
Results First Submitted: July 2, 2018
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019