Clinical trial NCT01702376 (phase 1, status: completed)
Conditions: obstetric labour, premature
ICD codes: O71.9, O71.3, O71.7, O71.89, O90.2, O71.4, O90.1
Drugs: retosiban 100 mg, retosiban 800 mg, placebo, moxifloxacin 400 mg
SMILES: CC[C@H](C)[C@H]1N([C@@H](C(=O)N2CCOCC2)C2=COC(C)=N2)C(=O)[C@H](NC1=O)C1CC2=CC=CC=C2C1, CC[C@H](C)[C@H]1N([C@@H](C(=O)N2CCOCC2)C2=COC(C)=N2)C(=O)[C@H](NC1=O)C1CC2=CC=CC=C2C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@]12CN(C[C@@]1([H])NCCC2)C1=C(F)C=C2C(=O)C(=CN(C3CC3)C2=C1OC)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  - Male or female between 18 and 45 years of age inclusive, at the time of signing the
             informed consent

          -  A female subject is eligible to participate if she is of: child-bearing potential and
             agrees to use the contraception methods from time of consent until until 48 hours post
             last dose; Non-childbearing potential defined as pre-menopausal females with a
             documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of
             spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose
             menopausal status is in doubt will be required to use the contraception methods if
             they wish to continue their HRT during the study. Otherwise, they must discontinue HRT
             to allow confirmation of post-menopausal status prior to study enrollment. For most
             forms of HRT, at least 2 to 4 weeks should elapse between the cessation of therapy and
             the blood draw; this interval depends on the type and dosage of HRT. Following
             confirmation of their post-menopausal status, they can resume use of HRT during the
             study without use of a contraceptive method.

          -  Healthy as determined by a responsible and experienced physician, based on a medical
             evaluation including medical history, physical examination, laboratory tests and
             cardiac monitoring. A subject with a clinical abnormality or laboratory parameters
             outside the reference range for the population being studied may be included only if
             the Investigator and the GlaxoSmithKline (GSK) Medical Monitor agree that the finding
             is unlikely to introduce additional risk factors and will not interfere with the study
             procedures.

          -  Body weight (greater than or equal to) >=50 kg and body mass index (BMI) within the
             range 19 to 29.9 kg/m^2

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

          -  No significant abnormality on 12-lead ECG at screening, including the following
             specific requirements: ventricular rate >=40 beats per minute, PR interval less than
             or equal to (<=) 210 miliseconds (msec), Q waves less than (<)30 msec, QRS interval to
             be >=60 msec and <120 msec; the waveforms must enable the QT interval to be clearly
             defined; QTcB or QTcF interval must be <450 msec

          -  ALT, alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin greater than (>)
             1.5x upper limit of normal (ULN) is acceptable if bilirubin is fractionated and direct
             bilirubin <35%)

        Exclusion Criteria:

          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
             result within 3 months of screening.

          -  A supine blood pressure that is persistently higher than 140/90 millimeters of mercury
             (mmHg).

          -  A supine mean heart rate outside the range 40 to 90 beats per minute (bpm).

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

          -  A positive pre-study drug/alcohol screen.

          -  A positive test for Human Immunodeficiency Virus (HIV) antibody.

          -  History of regular alcohol consumption within 6 months of the study defined as: an
             average weekly intake of >14 drinks for males or >7 drinks for females. One drink is
             equivalent to 12 g of alcohol: 12 ounces (360 ml [milliliters]) of beer, 5 ounces (150
             ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.

          -  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.

          -  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 serum human chorionic gonadotropin (hCG)
             test at screening or prior to dosing. Lactating females.

          -  Unwillingness or inability to follow the procedures outlined in the protocol.

          -  Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or
             nicotine-containing products within 6 months prior to screening.

          -  Unable to refrain from consumption of red wine, seville oranges, grapefruit or
             grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit
             juices from 7 days prior to the first dose of study medication.

          -  History or presence of any medically significant disease, or any disorder that would
             introduce additional risk or interfere with the study procedures or outcome. In
             particular, a family history of QT prolongation, of early or sudden cardiac death or
             of early cardiovascular disease.

          -  Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
             supplements from 14 days before screening until the follow-up visit unless in the
             opinion of the Investigator and sponsor the medication will not interfere with the
             study or compromise subject safety.

          -  Serum calcium, magnesium or potassium levels outside the reference range

          -  History of sensitivity to quinolone antibiotics 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.