Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
|ClinicalTrials.gov Identifier: NCT02209987|
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : October 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: GS-5745 SC Drug: GS-5745 IV||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: GS-5745 SC
Participants will receive a single dose of GS-5745 by SC injection.
Drug: GS-5745 SC
GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
Experimental: GS-5745 IV
Participants will receive a single dose of GS-5745 by IV infusion.
Drug: GS-5745 IV
GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
- PK profile of GS-5745 [ Time Frame: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8 ]
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:
- Cmax: maximum observed concentration of drug in plasma
- AUClast: concentration of drug from time zero to the last quantifiable concentration
- AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
- Incidences of adverse events and laboratory abnormalities [ Time Frame: Up to 8 weeks ]This composite endpoint will measure the safety and tolerability profile of GS-5745.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209987
|Christchurch, New Zealand|
|Study Director:||Bittoo Kanwar, MD||Gilead Sciences|