Adults 18 to 60, any sex, with Hypertension, Pulmonary. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1Primary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data.
Ambrisentan, Cmax
Group
Value
95% CI
Part 1,Treatment F1
766.29
± 18.2
Part 1,Treatment F2
685.33
± 20.5
Part 1,Treatment F3
738.49
± 22.1
Part 1,Treatment F4
722.57
± 27.7
Part 1, Treatment R
755.37
± 28.9
Tadalafil, Cmax
Group
Value
95% CI
Part 1,Treatment F1
581.41
± 27.6
Part 1,Treatment F2
595.47
± 22.3
Part 1,Treatment F3
588.11
± 24.5
Part 1,Treatment F4
590.36
± 21.4
Part 1, Treatment R
567.62
± 18.0
Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1Primary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples were collected at the indicated time-points. The analysis was done under fasting condition post single dose. There is no formal hypothesis tested for Part 1 of the study.
Ambrisentan, (AUC 0 - inf)
Group
Value
95% CI
Part 1,Treatment F1
5566.06
± 23.8
Part 1,Treatment F2
5556.44
± 25.9
Part 1,Treatment F3
5788.91
± 25.8
Part 1,Treatment F4
6007.57
± 23.7
Part 1, Treatment R
5746.73
± 20.8
Tadalafil, (AUC 0 - inf)
Group
Value
95% CI
Part 1,Treatment F1
13408.30
± 41.3
Part 1,Treatment F2
14415.47
± 41.8
Part 1,Treatment F3
14545.28
± 38.4
Part 1,Treatment F4
14418.35
± 37.8
Part 1, Treatment R
13955.85
± 36.2
AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1Primary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples at Part 1, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. The PK Parameter Population was used for analysis. There is no formal hypotheses tested for Part 1 of the study.
Ambrisentan, (AUC 0- t)
Group
Value
95% CI
Part 1,Treatment F1
5418.03
± 22.9
Part 1,Treatment F2
5434.88
± 25.3
Part 1,Treatment F3
5655.75
± 25.5
Part 1,Treatment F4
5858.18
± 22.9
Part 1, Treatment R
5605.58
± 20.2
Tadalafil, (AUC 0- t)
Group
Value
95% CI
Part 1,Treatment F1
12469.86
± 37.1
Part 1,Treatment F2
13307.95
± 37.4
Part 1,Treatment F3
13376.86
± 34.8
Part 1,Treatment F4
13238.89
± 33.4
Part 1, Treatment R
12805.01
± 32.2
Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2Primary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time-points, of Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Ambrisentan, (n=21,20,20,20)
Group
Value
95% CI
Part 2, Treatment R
710.90
± 28.2
Part 2, Treatment FG1
720.79
± 21.1
Part 2, Treatment FG2
748.63
± 22.9
Part 2, Treatment FG3
726.15
± 31.4
Tadalafil, (n=20,20,20,20)
Group
Value
95% CI
Part 2, Treatment R
537.80
± 27.6
Part 2, Treatment FG1
561.60
± 28.4
Part 2, Treatment FG2
550.78
± 28.6
Part 2, Treatment FG3
553.31
± 20.5
AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2Primary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting condition post single dose. PK parameter Populatio was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those pa
Ambrisentan, AUC (0-inf) (n=21,20,20,20)
Group
Value
95% CI
Part 2, Treatment R
6029.19
± 29.6
Part 2, Treatment FG1
6179.41
± 27.2
Part 2, Treatment FG2
6189.22
± 29.5
Part 2, Treatment FG3
6201.40
± 25.7
Tadalafil, AUC ( 0 - inf) (n=20,20,20,20)
Group
Value
95% CI
Part 2, Treatment R
14006.59
± 46.7
Part 2, Treatment FG1
14443.86
± 44.8
Part 2, Treatment FG2
14502.37
± 40.5
Part 2, Treatment FG3
14457.33
± 40.5
AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2Primary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. PK parameter Population was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=
Ambrisentan, (n=21,20,20,20)
Group
Value
95% CI
Part 2, Treatment R
5893.74
± 29.4
Part 2, Treatment FG1
6016.62
± 27.1
Part 2, Treatment FG2
6051.83
± 29.6
Part 2, Treatment FG3
6015.11
± 25.9
Tadalafil, (n=20,20,20,20)
Group
Value
95% CI
Part 2, Treatment R
12832.91
± 39.6
Part 2, Treatment FG1
13149.19
± 37.5
Part 2, Treatment FG2
13305.50
± 35.2
Part 2, Treatment FG3
13275.08
± 33.3
Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3APrimary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.
Ambrisentan, Cmax
Group
Value
95% CI
Part 3A,Treatment X1
550.02
± 30.9
Part 3A,Treatment X2
756.60
± 24.1
Part 3A,Treatment R1
515.61
± 33.4
Part 3A,Treatment R2
728.32
± 29.8
Tadalafil, Cmax
Group
Value
95% CI
Part 3A,Treatment X1
525.10
± 26.5
Part 3A,Treatment X2
508.72
± 24.9
Part 3A,Treatment R1
533.67
± 19.5
Part 3A,Treatment R2
520.62
± 21.1
AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3APrimary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48 and 72 hours post-dose. The analysis, was done under fed and fasting conditions post single dose. PK parameter population was used.
Ambrisentan, AUC (0-inf)
Group
Value
95% CI
Part 3A,Treatment X1
6075.51
± 26.1
Part 3A,Treatment X2
6231.48
± 25.1
Part 3A,Treatment R1
5898.72
± 27.7
Part 3A,Treatment R2
6155.60
± 24.4
Tadalafil, AUC (0-inf)
Group
Value
95% CI
Part 3A,Treatment X1
16086.66
± 41.5
Part 3A,Treatment X2
14856.32
± 40.0
Part 3A,Treatment R1
16596.18
± 37.8
Part 3A,Treatment R2
14612.84
± 41.5
AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3APrimary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.
Ambrisentan, AUC (0-t)
Group
Value
95% CI
Part 3A,Treatment X1
5926.87
± 25.7
Part 3A,Treatment X2
6090.74
± 24.8
Part 3A,Treatment R1
5766.71
± 27.4
Part 3A,Treatment R2
6012.51
± 24.0
Tadalafil, AUC (0-t)
Group
Value
95% CI
Part 3A,Treatment X1
14366.73
± 33.7
Part 3A,Treatment X2
13320.79
± 32.4
Part 3A,Treatment R1
14946.32
± 31.1
Part 3A,Treatment R2
13114.00
± 32.6
Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3BPrimary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose.
Ambrisentan, Cmax
Group
Value
95% CI
Part 3B,Treatment Y1
375.87
± 23.0
Part 3B,Treatment R3
380.47
± 26.2
Tadalafil, Cmax
Group
Value
95% CI
Part 3B,Treatment Y1
488.36
± 19.7
Part 3B,Treatment R3
511.80
± 28.3
AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3BPrimary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36,48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK Parameter Population was used for analysis.
Ambrisentan AUC (0-inf)
Group
Value
95% CI
Part 3B,Treatment Y1
3397.51
± 19.7
Part 3B,Treatment R3
3277.81
± 20.8
Tadalafil, AUC (0-inf)
Group
Value
95% CI
Part 3B,Treatment Y1
14724.34
± 39.7
Part 3B,Treatment R3
14938.29
± 40.7
AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3BPrimary· Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose
AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.
Ambrisentan, AUC (0-t)
Group
Value
95% CI
Part 3B,Treatment Y1
3297.16
± 19.8
Part 3B,Treatment R3
3190.51
± 20.3
Tadalafil, AUC (0-t)
Group
Value
95% CI
Part 3B,Treatment Y1
13119.89
± 31.0
Part 3B,Treatment R3
13325.63
± 35.0
Adverse events — posted to ClinicalTrials.gov
Time frame: All SAEs and AEs were collected from Day 1 to up to follow-up ( up to 165 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to understand the relative bioavailability (proportion of the administered dose that is absorbed into the bloodstream) of several fixed dose combinations (FDCs) tablets of ambrisentan and tadalafil for further development and to provide pharmacokinetic (PK - what the body does to the drug) data to enable a pivotal bioequivalence (BE - the relationship between two preparations of the same drug in the same dosage form that have a similar bioavailability) study. Depending on formulation work, the study will allow up to 8 new FDCs to be compared with the reference of ambrisentan and tadalafil monotherapies. The study will also evaluate up to 2 of the new formulations, that may be taken in to a BE study, to be tested for any effect on pharmacokinetics of the FDC in both fed and fasted state. This is a single centre, Phase 1, single dose, randomised, open label crossover study with 3 study parts; each study part will have up to a 5 way crossover in healthy subjects. Part 1 of the study will evaluate four formulations of the FDC (ambrisentan 10 milligram \[mg\] + tadalafil 40 mg) and the reference of the 2 monotherapy components taken concurrently (ambrisentan 10 mg and tadalafil 40 mg) in the fasted stated. If successful formulations are identified in this part of the study, then they will be re-formulated and tested in part 2. If no successful formulations are identified in part 1 of the study, then part 2 will be utilized to look at up to 4 new FDC formulations. However, if only two formulations, or less, are evaluated in part 2 then the FDC formulations may be tested both fed and fasted to assess food effect and part 3 will not be required. If successful formulations are identified in this study part, then up to 2 of these may be tested, for food effect, in Part 3 if not already assessed in this part. Therefore, part 3 is optional and utility is dependent on the results of the previous study parts.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 22 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02688387.