| Primary | Number of Participants With Vital Sign Values of Potential Clinical Concern | Vital signs included blood pressure (systolic and diastolic) and heart rate. Maternal blood pressure and heart rate were measured with the participant in the semi-supine position. Blood pressure was measured in millimeters of mercury (mmHg) and heart rate in beats per minute (bpm). Potential clinical concern range for systolic blood pressure: <85 and >160 mmHg, for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 bpm. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with vital sign values of potential clinical concern are presented. | Safety Population which comprised of all participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Up to Follow-up (Week 12) | | | | ID | Title | Description |
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| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG002 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. | | OG003 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
| | Units | Counts |
|---|
| Participants | - OG00020
- OG00130
- OG0029
- OG003
|
| | Title | Denominators | Categories |
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| High heart rate | | |
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| Primary | Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern | All scheduled 12-lead ECGs were obtained after the participant was rested in the semi-supine position for approximately 15 minutes. Whenever 12-lead ECGs were performed at the same nominal time as a blood draw or blood pressure and pulse rate measurement, the 12-lead ECG were obtained first. ECGs were repeated or recorded in triplicate and the average value recorded at the investigators discretion. The potential clinical concern range for ECG parameters were: Absolute QT corrected (QTc) interval: >450 milliseconds (msec), Increase from Baseline (Day 0): QTc >60 msec, PR interval: <110 and >220 msec and QRS interval: <75 and >110 msec. All 12-lead ECGs obtained throughout the study day were evaluated for safety and were reviewed by the investigator or investigator designee. Number of participants with electrocardiogram values of potential clinical concern are presented. | | Posted | | Count of Participants | | Participants | | Up to Follow-up (Week 12) | | | | ID | Title | Description |
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| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | |
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| Primary | Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical Concern | Hematology parameters included complete blood count with red blood cell indices and white blood cell differential, platelet count, human immune deficiency virus, Hepatitis C antibody and Hepatitis B surface antigen. Clinical chemistry parameters included blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, phosphate, chloride, total CO2, calcium, aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyltransferase (GGT), alkaline phosphatase, total bilirubin, uric acid, albumin and total protein. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry and hematology parameter values of potential clinical concern are presented. | | Posted | | Count of Participants | | Participants | | Up to 24 hours post-treatment | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. |
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| Primary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact. | | Posted | | Count of Participants | | Participants | | Up to Follow-up (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. |
|
| Primary | Assessment of Amniotic Fluid Index (AFI) | AFI is a quantitative estimate of amniotic fluid and an indicator of fetal well-being. AFI is the score (expressed in centimetes) given to the amount of amniotic fluid seen on ultrasonography of a pregnant uterus. An AFI between 8 to 18 is considered normal. An AFI < 5 to 6 is considered as oligohydramnios characterized by deficiency of amniotic fluid. An AFI > 18 to 24 is considered as polyhydramnios characterized by excess of amniotic fluid in the amniotic sac. | Pharmacodynamic Population which comprised of all participants who provided pharmacodynamic data. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm. | Posted | | Mean | Standard Deviation | Score | | Up to 48 hours-post dose | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. |
|
| Primary | Number of Participants With 50% Reduction in Uterine Contractions Per Hour in Part A and B | For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose.The number of participants that achieve a reduction of at least 50% in uterine contractions with no cervical change within 6 hours and to maintain that reduction until 12 hours of therapy has been presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL | | OG001 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Primary | Fetal Heart Rate Monitoring up to 48 Hours | Fetal heart rate monitoring was incorporated to assess fetal tolerability. Fetal heart rate was monitored continuously at 2, 4, 6, 8, 12, 18, 24, 36 and up to 48 hours post-therapy. Mean fetal heart rate is presented. Data for only key-time points values have been presented. | Pharmacodynamic Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm. | Posted | | Mean | Standard Deviation | Beats per minute | | Up to 48 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG002 | Part A/B: Oral GSK221149A |
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| Primary | Number of Participants Achieving Uterine Quiescence | Uterine quiescence was defined as 4 contractions per/hour or less with no cervical change within the first 6 hours of therapy. Number of participants (from part A,B,C) achieving uterine Quiescence are presented. | Pharmacodynamic Population. | Posted | | Count of Participants | | Participants | | Up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG002 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Number of Participants With Preterm Births in Part C | Preterm is defined as babies born alive before 37 weeks of pregnancy are completed. There are sub-categories of preterm birth, based on gestational age: extremely preterm (<28 weeks) very preterm (28 to <32 weeks). Number of participants with preterm births are presented. | Pharmacodynamic Population. | Posted | | Count of Participants | | Participants | | Up to 48 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
| |
| Secondary | Neonatal Apgar Scores in Part A and B | APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition. | Pharmacodynamic Population. | Posted | | Mean | Standard Deviation | Scores on a Scale | | 1 minute and 5 minutes after birth | | | | ID | Title | Description |
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| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
|
| Secondary | Neonatal Weight Gain in Part A and B | Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Grams | | At birth and Follow-up (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Neonatal Head Circumference in Part A and B | Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Centimeters | | At Birth and Follow-up (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Neonatal Length Measured at 4-6 Weeks of Age in Part A and B | Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (approximately 4 to 6 weeks of age). Mean Neonatal length is presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Centimeters | | At birth and follow-up (approximately 4 to 6 weeks of age) | | | | ID | Title | Description |
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| OG000 | Part A/B: IV GSK221149A | Eligible participants received a single IV infusion of GSK221149A over 12 hours followed by a single oral dose of placebo tablets of strength 125 mg matched to GSK221149A. The GSK221149 loading dose and infusion rate were increased in a stepwise fashion every 3 hours to achieve plasma concentrations of 10, 30, 75, and 150 ng/mL. | | OG001 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Derived Plasma GSK221149 Pharmacokinetic Parameters- Area Under Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) and Area Under Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC [0 to Last]) | Blood samples (approximately 2mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion. | Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter | | Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion | | | | ID | Title | Description |
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| OG000 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Derived Plasma GSK221149 Pharmacokinetic Parameters- Observed Elimination Half-life (T-half) and Time to Maximum Observed Drug Concentration (T-max) | Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion. | Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters | Posted | | Mean | Standard Deviation | Hours | | Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion | | | | ID | Title | Description |
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| OG000 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Derived Plasma GSK221149 Pharmacokinetic Parameters- Maximum Plasma Concentration (Cmax) | Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion. | Safety Population. Only those participants who received oral GSK221149A 125 mg were assessed for PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | | Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion | | | | ID | Title | Description |
|---|
| OG000 | Part A/B: Oral GSK221149A | Eligible participants received placebo IV infusion over 12 hours followed by a single oral dose of GSK221149 125 mg tablets. The placebo loading dose and infusion rate were also increased every 3 hours in a stepwise fashion. |
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| Secondary | Neonatal Apgar Scores (at Birth) Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C | APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition. | Pharmacodynamic Population. | Posted | | Mean | Standard Deviation | Scores on a scale | | 1 minute and 5 minute after birth at 4 to 12 weeks post adjusted gestational age | | | | ID | Title | Description |
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| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
|
| Secondary | Neonatal Weight Gain Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C | Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Grams | | At birth and Follow-up (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
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| Secondary | Neonatal Head Circumference Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C | Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Centimeteres | | At Birth and Follow-up (Week 12) | | | | ID | Title | Description |
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| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
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| Secondary | Neonatal Length Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C | Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (Week 12). Mean neonatal length is presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Centimeters | | At Birth and Follow-up (Week 12) | | | | ID | Title | Description |
|---|
| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
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| Secondary | Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C | Tocolytics are medications used to suppress premature labor. They are given when delivery would result in premature birth. Number of participants who remained undelivered without rescue tocolytic therapy after 48 hours are presented. | Pharmacodynamic Population. | Posted | | Count of Participants | | Participants | | 48 hours post-dose | | | | ID | Title | Description |
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| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
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| Secondary | Percentage Reduction From Baseline in Number of Uterine Contractions [>30 Sec] Per Hour Within First 6 Hours of Therapy in Part C | For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose. Baseline was Day 0. Reduction from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percentage reduction from Baseline in number of uterine contractions [>30 sec] per hour within first 6 hours of therapy are presented. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Posted | | Mean | Standard Deviation | Percent change | | First 6 hours of therapy | | | | ID | Title | Description |
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| OG000 | Part C: Active (GSK221149A) | Each participant received a loading dose of 6 mg GSK221149A over 5 minutes, followed by a constant IV infusion of 6 mg/h GSK221149A over 48 hours to reach a Css,ave of 75 ng/mL. | | OG001 | Part C: Placebo | Each participant received a loading dose of placebo over 5 minutes, followed by a constant IV infusion of placebo over 48 hours. |
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