Trial Outcomes & Findings for A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age (NCT NCT06354257)

The Combined Participants Group includes all participants from the 3 treatment periods combined. This group was used to summarize Participant Flow and Baseline Characteristics in the study.

A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age

AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis.

Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.

AUC(0-tau) is defined as the area under the concentration-time curve over a dosing interval and was calculated by using a non-compartmental analysis.

Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.

Ctau is defined as the concentration reached by the drug immediately before the next dose is administered.

Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data.

AUC(0-t) is defined as area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration and was calculated by using a non-compartmental analysis.

Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data.

t1/2 is defined as the time required by the plasma concentration to decline by 50% and was calculated by using a non-compartmental analysis.

A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity.

The drug-related AEs were assessed by the investigator to be possibly, probably or definitely related to the study interventions.

Adverse events resulting in withholding of study intervention administration were included in this outcome measure.

PCI ECG values are defined as any ECG findings which, in the opinion of the investigator or medical monitor would interfere with the safety of the individual participant. The ECG measurements analyzed are PR Interval, QRS Duration, and QTcF Interval. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.

The chemistry parameters analyzed are homocysteine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, bilirubin, calcium, creatine kinase, potassium, protein, sodium, urea, and glucose. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.

The analyzed hematology parameters are reticulocytes/erythrocytes, monocytes/leukocytes, erythrocytes, basophils/leukocytes, eosinophils/leukocytes, mean corpuscular hemoglobin, hematocrit, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.

The analyzed vital signs are systolic blood pressure, diastolic blood pressure, heart rate, body temperature, and respiration rate. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.