Clinical trial NCT01262911 (phase 1, status: completed)
Conditions: sepsis
ICD codes: A02.1, A22.7, A26.7, A32.7, A42.7, A54.86, B37.7
Drugs: srt2379, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, as determined by a responsible and experienced physician, based on a medical
             evaluation including medical history, physical examination and laboratory tests
             carried out within 21 days prior to dosing.

          -  Male between 18 and 35 years of age inclusive, at the time of signing the informed
             consent

          -  Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the consent form

          -  Chemistry panel, including renal and liver functions tests, without any clinically
             relevant abnormality

          -  Subjects must agree with their partners to use double-barrier birth control or
             abstinence while participating in the study and for 7 days following the dose of study
             drug

        Exclusion Criteria:

          -  Subject has had a major illness in the past 3 months or any significant chronic
             medical illness that the investigator would deem unfavorable for enrollment including
             inflammatory diseases

          -  Subjects with a history of any type of malignancy with the exception of successfully
             treated basal cell cancer of the skin

          -  Subject has a past or current gastrointestinal disease which may influence drug
             absorption

          -  The subject has a known positive test for hepatitis C antibody, hepatitis B surface
             antigen or HIV

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones)

          -  Subject has a history, within three years, of drug abuse (including benzodiazepines,
             opioids, amphetamine, cocaine, THC) or a positive drug results at the Screening visit

          -  History of alcoholism and/or is drinking more than 3 drinks per day. Alcoholism is
             defined as an average weekly intake of >21 units for males or >14 units for females.
             One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125
             mL) of wine or 1 (25 mL) measure of spirits

          -  The subject has participated in a clinical trial and has received an investigational
             product within three months of the dosing in the current study

          -  Use of prescription or non-prescription drugs, and herbal and dietary supplements
             within 7 days unless in the opinion of the Investigator and Medical Monitor the
             medication will not interfere with the study procedures or compromise subject safety

          -  Subject has difficultly in donating blood or accessibility of a vein in left or right
             arm

          -  Subject has donated more than 350 mL of blood in last 3 months

          -  Subject uses tobacco products

          -  Any clinically relevant abnormality noted on the 12-lead ECG as judged by the
             investigator or an average QTcB or QTcF > 450 msec

          -  Any other issue that, in the opinion of the Principal Investigator, would could be
             harmful to the subject or compromise interpretation of the data

          -  Prior participation in a trial where the subject received IV LPS