A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Selgantolimod upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist
Phase 1
Completed
- Conditions
- Hepatitis BOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonInfection - Other infectious diseases
- Registration Number
- ACTRN12620001019998
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Screening laboratory evaluations and 12-lead ECG evaluations must be without clinically
significant abnormalities as assessed by the investigator
- Must, in the opinion of the investigator, be in good health based upon medical history and
physical examination, including vital signs
Exclusion Criteria
- Pregnant or Breastfeeding
- Have received any study drug within 30 days prior to study dosing
- Have poor venous access that limits phlebotomy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - PK parameters AUC last, Cmax, and AUC inf of Selgantolimod with or without PPI via blood samples. <br><br>[Cohort 1:<br>Days 1, 9<br><br>Cohort 2:<br>Days 1, 8, 15, 22];- PK parameters AUC last, Cmax, and AUC inf of Selgantolimod with or without H2RA via blood samples. <br>[Cohort 1:<br>Days 1, 9<br><br>Cohort 2:<br>Days 1, 8, 15, 22]
- Secondary Outcome Measures
Name Time Method - Incidences of AEs including Nausea, Vomiting, Headache or fatigue assessed by the site investigators during discussions with participants. <br>[Daily <br><br>Cohort 1<br>Day 1-8<br><br>Cohort 2<br>Day 1-23];- Incidences of laboratory abnormalities via blood samples. <br>[Cohort 1:<br>Days 8, 10, EOT<br><br>Cohort 2:<br>Days 7, 14, 21, 23, EOT];- Relevant PD markers of staggered and/or co-administration of Selgantolimod with H2RA and PPI versus Selgantolimod alone via blood samples. <br>[Cohort 1:<br>Days 1, 4, 9<br><br>Cohort 2:<br>Days 1, 8, 15, 22]