Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1 Study to Demonstrate the Relative Bioavailability of Fixed Dose Combinations of Ambrisentan and Tadalafil in Healthy Subjects
Brief Summary: 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.


Options:
A: Intervention Type: DRUG; Name: bosentan; Assigned to Arm(s): N/A
B: Arm Label: Part 1; Type: EXPERIMENTAL; Interventions: Drug: FDC (ambrisentan 10 mg-tadalafil 40 mg) single dose, Drug: Reference (ambrisentan 10 mg + tadalafil 40 mg given concurrently) | Arm Label: Part 2; Type: EXPERIMENTAL; Interventions: Drug: FDC (ambrisentan 10 mg-tadalafil 40 mg) single dose, Drug: Reference (ambrisentan 10 mg + tadalafil 40 mg given concurrently) | Arm Label: Part 3; Type: EXPERIMENTAL; Interventions: Drug: FDC (ambrisentan 10 mg-tadalafil 40 mg) single dose | Intervention Type: DRUG; Name: FDC (ambrisentan 10 mg-tadalafil 40 mg) single dose; Assigned to Arm(s): Part 1, Part 2, Part 3 | Intervention Type: DRUG; Name: Reference (ambrisentan 10 mg + tadalafil 40 mg given concurrently); Assigned to Arm(s): Part 1, Part 2
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Aprocitentan 5 mg; Type: EXPERIMENTAL; Interventions: Drug: Aprocitentan 5 mg | Arm Label: Aprocitentan 10 mg; Type: EXPERIMENTAL; Interventions: Drug: Aprocitentan 10 mg | Arm Label: Aprocitentan 25 mg; Type: EXPERIMENTAL; Interventions: Drug: Aprocitentan 25 mg | Arm Label: Aprocitentan 50 mg; Type: EXPERIMENTAL; Interventions: Drug: Aprocitentan 50 mg | Arm Label: Lisinopril 20 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lisinopril 20 mg | Intervention Type: DRUG; Name: Aprocitentan 5 mg; Assigned to Arm(s): Aprocitentan 5 mg | Intervention Type: DRUG; Name: Aprocitentan 10 mg; Assigned to Arm(s): Aprocitentan 10 mg | Intervention Type: DRUG; Name: Aprocitentan 25 mg; Assigned to Arm(s): Aprocitentan 25 mg | Intervention Type: DRUG; Name: Aprocitentan 50 mg; Assigned to Arm(s): Aprocitentan 50 mg | Intervention Type: DRUG; Name: Lisinopril 20 mg; Assigned to Arm(s): Lisinopril 20 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Investigational treatment; Type: EXPERIMENTAL; Interventions: Drug: Macitentan | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Macitentan; Assigned to Arm(s): Investigational treatment | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: B