Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01831427
• Date of registration: 08/04/2013
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis
• Scientific title: A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis
• Date of first enrolment: March 2013
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01831427
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

Belgium, Canada, Hungary, Moldova, Republic of, Netherlands, Romania, United States

Contacts

• Name: Bittoo Kanwar, MD
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or Female, 18 to 65 years of age

- Negative pregnancy test at screening

- Documented diagnosis of ulcerative colitis (UC) with a minimum disease extent of 15 cm
from the anal verge

- Mayo Score of at least 3 for the SAD cohort and Mayo Score of at least 6 for the MAD
cohorts

- Hepatic panel (aspartate aminotransferase [AST], alanine aminotransferase [ALT], total
bilirubin, direct bilirubin, alkaline phosphatase, lactate dehydrogenase [LDH] = 2
times the upper limit of the normal range [ULN])

- Serum creatinine = 1.5 times the ULN

- Hemoglobin = 10 g/dL (both males and females)

- Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1,500 mm^3)

- Platelets = 100 x 10^9/L

Exclusion Criteria:

- Pregnant or lactating females

- Exhibit severe UC/ clinically significant active infection

- Current use of oral corticosteroids at a dose equivalent to > 20 mg/day of prednisone

- Any dose adjustment in oral corticosteroids or oral immunosuppressants (6-MP,
Azathioprine), or oral 5-ASA compounds within 30 days of Baseline

- Use of rectal formulations of 5-ASA compounds or corticosteroids within 2 weeks prior
to randomization

- Crohn's disease or indeterminate colitis

- History of colectomy, partial colectomy, or dysplasia on biopsy

- Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli,
Salmonella, Shigella, Campylobacter or Yersinia

- Treatment with Infliximab, Adalimumab, Natalizumab, Golimumab, Vedolizumab or
Certolizumab within 8 weeks of randomization

- Any chronic medical condition (including, but not limited to, cardiac or pulmonary
disease) that, in the opinion of the Investigator, would make the individual
unsuitable for the study or would prevent compliance with the study protocol



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: GS-5745

Drug: Placebo to match GS-5745

Primary Outcome(s)

Evaluating the safety and tolerability throughout the duration of the study [Time Frame: SAD Cohort: through Day 41, MAD/Adaptive MAD Cohort: through Day 71]

Pharmacokinetics (PK) of GS-5745 following SAD and MAD/adaptive MAD doses of GS-5745 [Time Frame: SAD Cohort: through Day 43; MAD/Adaptive MAD Cohort: through Day 71]

Secondary Outcome(s)

Pharmacokinetics (PK) of GS-5745 following SAD and MAD/adaptive MAD doses of GS-5745 [Time Frame: SAD Cohort: through Day 43; MAD/Adpative MAD Cohort: through Day 71]

Secondary ID(s)

GS-US-326-0101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors