Last updated: 06/29/2019 12:10:22
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged during Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase I, First Time in Human, Two Part, Randomized, Placebo-Controlled, Double-Blind (Sponsor Unblind), Single and Repeat Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK3352589, a REarranged during Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
Trial description: This FTIH study is designed to assess the safety, tolerability and pharmacokinetic (PK) of escalating single and repeat oral doses of GSK3352589 in normal healthy volunteers. This is a randomized, double-blind (sponsor unblinded), placebo controlled, dose escalation study that will have two parts; Part A and Part B.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of subjects with adverse event (AE) and serious adverse event (SAE) for Part A and Part B
Timeframe: Up to 10 weeks
Area under the plasma concentration-time curve (AUC) over the dose interval
Timeframe: Pre-dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36 and 48 hour (h) postdose
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK3352589
Drug: Matching Placebo
Enrollment:
68
Observational study model:
Not applicable
Primary completion date:
2018-05-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Bowel Syndrome
Product
GSK3352589
Collaborators
Not applicable
Study date(s)
May 2017 to March 2018
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. - History of regular bowel habits
- ALT and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Previous Diagnosis of IBS
Inclusion and exclusion criteria
Inclusion criteria:
- Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- History of regular bowel habits
- Male or Female of non-childbearing potential.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Exclusion criteria:
- ALT and bilirubin >1.5 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Previous Diagnosis of IBS
- Estimated Glomerular Filtration Rate <60 millilter per minute per 1.73 square meter (mL/min/1.73m^2)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- History of Gastroesophageal reflux disease (GERD), dyspepsia, Gastrointestinal (GI) bleeding, diverticulitis, diverticular stricture or other intestinal strictures, GI surgery that could affect motility
- Unwillingness or inability to follow the procedures outlined in the protocol
Trial location(s)
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2018-05-03
Actual study completion date
2018-05-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website