A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects
Status and phase
Completed
Phase 1
Conditions
Infections, Bacterial
Treatments
Drug: GSK1322322/placebo and midazolam
Drug: GSK1322322/placebo
Details and patient eligibility
About
This study will be the first repeat dose administration of GSK1322322 to investigate safety, tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects. The study will also include a P450 probe drug (midazolam) to evaluate the effect of GSK1322322 to inhibit or induce CYP3A4 substrates.
Enrollment
52 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- The subject is healthy.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent (except for elderly cohort-Part B, see #8 below)..
- A female is eligible to enter and participate in this study if she is of non-childbearing potential
- Male subjects must agree to use one of the contraception methods in the protocol
- Body weight greater than or equal to 50 kg and body mass index between 18.5-29.9 kg/m2 inclusive
- Capable of giving written informed consent
- QTcB less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block on Screening ECG
- Part B/Cohort E Elderly cohort: The subject is greater than 65 years of age.
Exclusion criteria
- The subject has a positive pre-study drug/alcohol screen.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined in the protocol
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive human chorionic gonadotropin test at screening or prior to dosing.
- Lactating females.
- Subjects who have asthma or a history of asthma within the past 6 months.
- History of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, satsuma, ugli, tangerine, and tangelo, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- For probe cohort in Part A: any condition or symptom contraindicated for administration of midazolam including acute narrow-angle or open-angle glaucoma.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Triple Blind
52 participants in 5 patient groups
Cohort A
Experimental group
Description:
A single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12.
Treatment:
Drug: GSK1322322/placebo
Cohort B
Experimental group
Description:
Subjects will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12.
Treatment:
Drug: GSK1322322/placebo
Cohort C
Experimental group
Description:
Subjects in the probe cohort will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12. All subjects will receive a single dose of midazolam alone on Day -1, and co-administered with the morning dose of GSK1322322/placebo on Day 1 and Day 12.
Treatment:
Drug: GSK1322322/placebo
Drug: GSK1322322/placebo and midazolam
Cohort D
Experimental group
Description:
Subjects will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12.
Treatment:
Drug: GSK1322322/placebo
Cohort E
Experimental group
Description:
Subjects will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12.
Treatment:
Drug: GSK1322322/placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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