Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pilot Trial of Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous Cystic Fibrosis Patients
Brief Summary: We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF.

Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: VX-809, 25 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Arm Label: VX-809, 50 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Arm Label: VX-809, 100 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Arm Label: VX-809, 200 mg; Type: EXPERIMENTAL; Interventions: Drug: VX-809 | Intervention Type: DRUG; Name: VX-809; Assigned to Arm(s): VX-809, 100 mg, VX-809, 200 mg, VX-809, 25 mg, VX-809, 50 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Part A: Pooled Placebo (Except Cohort A7); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part A: VX-445 (Except Cohort A7); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part A: VX-445 (Cohort A7); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part B: Pooled Placebo (Cohort B1 to B4); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part B: VX-445 (Cohort B1 to B4); Type: EXPERIMENTAL; Interventions: Drug: VX-445 | Arm Label: Part C: Pooled Placebo (Cohort C1 to C3); Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3); Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part D: VX-445/TEZ/IVA TC - Low Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: VX-445/TEZ/IVA TC - Medium Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part D: VX-445/TEZ/IVA TC - High Dose; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part E: TEZ/IVA; Type: ACTIVE_COMPARATOR; Interventions: Drug: TEZ/IVA | Arm Label: Part E: VX-445/TEZ/IVA TC; Type: EXPERIMENTAL; Interventions: Drug: IVA, Drug: TEZ/IVA, Drug: VX-445 | Arm Label: Part F: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Matched Placebo | Arm Label: Part F: VX-445/TEZ/VX-561 TC; Type: EXPERIMENTAL; Interventions: Drug: VX-445, Drug: TEZ, Drug: VX-561 | Intervention Type: DRUG; Name: IVA; Assigned to Arm(s): Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: TEZ/IVA; Assigned to Arm(s): Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: TEZ/IVA, Part E: VX-445/TEZ/IVA TC | Intervention Type: DRUG; Name: VX-445; Assigned to Arm(s): Part A: VX-445 (Cohort A7), Part A: VX-445 (Except Cohort A7), Part B: VX-445 (Cohort B1 to B4), Part C: VX-445/TEZ/IVA TC (Cohort C1 to C3), Part D: VX-445/TEZ/IVA TC - High Dose, Part D: VX-445/TEZ/IVA TC - Low Dose, Part D: VX-445/TEZ/IVA TC - Medium Dose, Part E: VX-445/TEZ/IVA TC, Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: Matched Placebo; Assigned to Arm(s): Part A: Pooled Placebo (Except Cohort A7), Part B: Pooled Placebo (Cohort B1 to B4), Part C: Pooled Placebo (Cohort C1 to C3), Part D: Placebo, Part F: Placebo | Intervention Type: DRUG; Name: TEZ; Assigned to Arm(s): Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-561; Assigned to Arm(s): Part F: VX-445/TEZ/VX-561 TC | Intervention Type: DRUG; Name: VX-445; Assigned to Arm(s): Part A: VX-445 (Cohort A7)
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sodium 4-Phenylbutyrate (4PBA), Drug: Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein), Drug: Placebo | Intervention Type: DRUG; Name: Sodium 4-Phenylbutyrate (4PBA); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein); Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
D: Arm Label: Group 1 - 50 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Group 2 - 100 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Group 3 - 200 mg; Type: EXPERIMENTAL; Interventions: Drug: N91115 | Arm Label: Group 4 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: N91115 | Intervention Type: DRUG; Name: N91115; Assigned to Arm(s): Group 1 - 50 mg, Group 2 - 100 mg, Group 3 - 200 mg, Group 4 - Placebo

Answer: C