Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects
Brief Summary: This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.


Options:
A: Inclusion Criteria:

* Healthy male and female subjects as defined in the protocol
* Subjects who weigh \>50 kg at Screening

Exclusion Criteria:

* History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV
* Standard 12-lead ECG demonstrating QTc \>450 msec for male subjects and \>480 msec for female subjects at the Screening Visit
* Abnormal renal function as defined in the protocol at Screening
* Forced expiratory volume in 1 second (FEV1) \<80% predicted at the Screening Visit
* Blood donation (of approximately 1 pint \[500 mL\] or more) within 56 days before the first dose of study drug
* Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug
B: Key Inclusion Criteria:

* Participants will be 1 to less than 2 years of age on day 1 of the relevant part of the study
* Homozygous for F508del (F/F)

Key Exclusion Criteria:

* Any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the participants
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply.
C: Key Inclusion Criteria:

* Completed study drug treatment in parent study (VX19-445-116, NCT04353817), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the treatment period in the parent study

Key Exclusion Criteria:

* History of study drug intolerance in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply
D: Inclusion Criteria:

Patients must meet all of the following conditions to be eligible for enrollment into the study:

* Completion of ≥ 1 cycle of PTC124 treatment in the previous Phase 2a study protocol (Protocol Number PTC124-GD-005-CF).
* Abnormal nasal epithelial TEPD total chloride conductance (a more electrically negative value than -5 mV for Δchloride-free+isoproterenol).
* FEV1 ≥ 40% of predicted for age, gender, and height.
* Oxygen saturation (as measured by pulse oximetry) ≥92% on room air.
* Willingness of male and female patients, if not surgically sterile, to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and follow-up periods.
* Negative pregnancy test (for females of childbearing potential).
* Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, and study restrictions.
* Ability to provide written informed consent.
* Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

The presence of any of the following conditions will exclude a patient from enrollment in the study:

* Prior or ongoing medical condition, medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the patient, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
* Ongoing acute illness including acute upper or lower respiratory infections within 2 weeks before start of study treatment in this study.
* History of major complications of lung disease (including recent massive hemoptysis or pneumothorax) within 2 months prior to start of study treatment in this study.
* Abnormalities on screening chest x-ray suggesting clinically significant active pulmonary disease other than CF, or new, significant abnormalities such as atelectasis or pleural effusion which may be indicative of clinically significant active pulmonary involvement secondary to CF.
* Hemoglobin \<10 g/dL.
* Serum albumin \<2.5 g/dL.
* Abnormal liver function (serum total bilirubin \> the upper limit of normal, or serum ALT, AST, or GGT \>2.0 times the upper limit of normal). Abnormal renal function (serum creatinine \>1.5 times upper limit of normal).
* Pregnancy or breast-feeding.
* History of solid organ or hematological transplantation.
* Exposure to another investigational drug within 14 days prior to start of study treatment in this study.
* Ongoing participation in any other therapeutic clinical trial.
* Ongoing use of thiazolidinedione peroxisome proliferator-activated receptor gamma (PPAR γ) agonists, eg, rosiglitazone (Avandia® or equivalent) or pioglitazone (Actos® or equivalent).
* Change in intranasal medications (including use of corticosteroids, cromolyn, ipratropium bromide, phenylephrine, or oxymetazoline) within 7 days prior to start of study treatment in this study.
* Change in treatment with systemic or inhaled corticosteroids within 7 days prior to start of study treatment in this study.
* Use of or requirement for inhaled gentamicin or amikacin within 14 days prior to start of study treatment in this study or during study treatment.
* Requirement for systemic aminoglycoside antibiotics within 14 days prior to start of study treatment in this study.

Answer: A