Cystic Fibrosis
Conditions
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in CF subjects 2 through 5 years of age.
Interventions
DRUGELX/TEZ/IVA
Fixed dose combination granules for oral administration.
DRUGIVA
Granules for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Homozygous for the F508del mutation or heterozygous for F508del and a minimal function (MF) mutation (F/F or F/MF genotypes) Key
Exclusion criteria
* Clinically significant cirrhosis with or without portal hypertension * Lung infection with organisms associated with a more rapid decline in pulmonary status * Solid organ or hematological transplantation Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | From Day 1 through Day 15 |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 43 |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Day 1 up to Week 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | From Day 1 through Week 16 | — |
| Part B: Absolute Change in Sweat Chloride (SwCl) | From Baseline through Week 24 | Sweat samples were collected using an approved collection device. |
| Part B: Absolute Change in Lung Clearance Index 2.5 (LCI 2.5) | From Baseline through Week 24 | The LCI2.5 index is the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting values and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured functional residual capacity (FRC). An LCI of 7.5 and below is normal; values greater than 7.5 are abnormal. LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry. |
Countries
Australia, Canada, Germany, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted in 2 parts, Part A and Part B. The Participant flow was planned to be presented for the overall treatment arms (i.e. Part A and Part B), irrespective of weight-based dose regimen.
Pre-assignment details
This study was conducted in participants with cystic fibrosis (CF) aged 2 through 5 years of age (inclusive).
Participants by arm
| Arm | Count |
|---|---|
| ELX/TEZ/IVA Part A: Participants weighing greater than or equal to (\>=)14 kilograms (kg) at screening received ELX 100 milligrams (mg) once daily (qd)/TEZ 50 mg qd/IVA 75 mg every 12 hours (q12h) in the treatment period for 15 days.
Part B: Participants weighing \>=14 kg at screening received ELX 100mg qd/TEZ 50mg qd/IVA 75 mg q12h and participants weighing \>=10 kg to less than (\<)14 kg received ELX 80mg qd/TEZ 40mg qd/IVA 60 mg once every morning (qAM) and IVA 59.5 mg once every evening (qPM) in the treatment period for 24 weeks. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part B (24 Weeks) | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | ELX/TEZ/IVA |
|---|---|
| Age, Categorical Part A <=18 years | 18 Participants |
| Age, Categorical Part A >=65 years | 0 Participants |
| Age, Categorical Part A Between 18 and 65 years | 0 Participants |
| Age, Categorical Part B <=18 years | 75 Participants |
| Age, Categorical Part B >=65 years | 0 Participants |
| Age, Categorical Part B Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized Part A Black or African American | 0 Participants |
| Race/Ethnicity, Customized Part A Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Part A Not collected per local regulations | 0 Participants |
| Race/Ethnicity, Customized Part A Not Hispanic or Latino | 18 Participants |
| Race/Ethnicity, Customized Part A White | 18 Participants |
| Race/Ethnicity, Customized Part B Black or African American | 1 Participants |
| Race/Ethnicity, Customized Part B Hispanic or Latino | 6 Participants |
| Race/Ethnicity, Customized Part B Not collected per local regulations | 6 Participants |
| Race/Ethnicity, Customized Part B Not Hispanic or Latino | 63 Participants |
| Race/Ethnicity, Customized Part B White | 68 Participants |
| Sex: Female, Male Part A Female | 11 Participants |
| Sex: Female, Male Part A Male | 7 Participants |
| Sex: Female, Male Part B Female | 41 Participants |
| Sex: Female, Male Part B Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 75 |
| other Total, other adverse events | 15 / 18 | 71 / 75 |
| serious Total, serious adverse events | 0 / 18 | 2 / 75 |
Outcome results
Primary
Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites
Time frame: From Day 1 through Day 15
Population: Pharmacokinetic (PK) set included participants who received at least 1 dose of study drug. Here the Number Analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 1: ELX | 0.00 micrograms per milliliter (mcg/ml) | Standard Deviation 0 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 8: ELX | 3.44 micrograms per milliliter (mcg/ml) | Standard Deviation 2.09 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 15: ELX | 3.69 micrograms per milliliter (mcg/ml) | Standard Deviation 2.11 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 1: ELX-M23 | 0.00 micrograms per milliliter (mcg/ml) | Standard Deviation 0 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 8: ELX-M23 | 2.39 micrograms per milliliter (mcg/ml) | Standard Deviation 1.65 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 15: ELX-M23 | 2.47 micrograms per milliliter (mcg/ml) | Standard Deviation 1.65 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 1: TEZ | 0.00 micrograms per milliliter (mcg/ml) | Standard Deviation 0 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 8: TEZ | 1.86 micrograms per milliliter (mcg/ml) | Standard Deviation 1.07 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 15: TEZ | 1.85 micrograms per milliliter (mcg/ml) | Standard Deviation 1.1 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 1: TEZ-M1 | 0.00 micrograms per milliliter (mcg/ml) | Standard Deviation 0 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 8: TEZ-M1 | 6.42 micrograms per milliliter (mcg/ml) | Standard Deviation 1.42 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 15: TEZ-M1 | 7.68 micrograms per milliliter (mcg/ml) | Standard Deviation 1.52 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 1: IVA | 0.00 micrograms per milliliter (mcg/ml) | Standard Deviation 0 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 8: IVA | 0.702 micrograms per milliliter (mcg/ml) | Standard Deviation 0.503 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 15: IVA | 0.746 micrograms per milliliter (mcg/ml) | Standard Deviation 0.526 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 1: IVA-M1 | 0.00 micrograms per milliliter (mcg/ml) | Standard Deviation 0 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 8: IVA-M1 | 1.78 micrograms per milliliter (mcg/ml) | Standard Deviation 0.99 |
| Part A: ELX/TEZ/IVA | Part A: Observed Pre-dose Concentration (Ctrough) of ELX,TEZ,IVA, and Relevant Metabolites | Day 15: IVA-M1 | 1.91 micrograms per milliliter (mcg/ml) | Standard Deviation 0.99 |
Primary
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 43
Population: Safety set for Part A included all participants who received at least 1 dose of study drug in Part A. This outcome measure was planned only for Part A arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: ELX/TEZ/IVA | Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with TEAEs | 15 participants |
| Part A: ELX/TEZ/IVA | Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 0 participants |
Primary
Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Week 28
Population: Safety set for Part B included all participants who received at least 1 dose of study drug in Part B. The safety and tolerability analysis for Part B was assessed for the overall treatment arm, irrespective of weight-based dose regimen. Therefore, the analysis is reported for the single triple combination (Part B: ELX/TEZ/IVA) arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: ELX/TEZ/IVA | Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with TEAEs | 74 participants |
| Part A: ELX/TEZ/IVA | Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 2 participants |
Secondary
Part B: Absolute Change in Lung Clearance Index 2.5 (LCI 2.5)
The LCI2.5 index is the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting values and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured functional residual capacity (FRC). An LCI of 7.5 and below is normal; values greater than 7.5 are abnormal. LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry.
Time frame: From Baseline through Week 24
Population: FAS (Part B). The efficacy analysis for Part B was assessed for the overall treatment arm, irrespective of weight-based dose regimen. Therefore, the analysis is reported for the single triple combination (Part B: ELX/TEZ/IVA) arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A: ELX/TEZ/IVA | Part B: Absolute Change in Lung Clearance Index 2.5 (LCI 2.5) | -0.83 index |
Secondary
Part B: Absolute Change in Sweat Chloride (SwCl)
Sweat samples were collected using an approved collection device.
Time frame: From Baseline through Week 24
Population: FAS (Part B). The efficacy analysis for Part B was assessed for the overall treatment arm, irrespective of weight-based dose regimen. Therefore, the analysis is reported for the single triple combination (Part B: ELX/TEZ/IVA) arm.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Part A: ELX/TEZ/IVA | Part B: Absolute Change in Sweat Chloride (SwCl) | -57.9 millimole per liter (mmol/L) |
Secondary
Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites
Time frame: From Day 1 through Week 16
Population: PK set included participants who received at least 1 dose of study drug. Here the Number Analyzed signifies those participants who were evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: TEZ-M1 | 6.88 micrograms per milliliter (mcg/ml) | Standard Deviation 1.94 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: ELX | 3.01 micrograms per milliliter (mcg/ml) | Standard Deviation 1.11 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: ELX-M23 | 1.85 micrograms per milliliter (mcg/ml) | Standard Deviation 1.12 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: ELX-M23 | 2.32 micrograms per milliliter (mcg/ml) | Standard Deviation 2.01 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: TEZ | 1.62 micrograms per milliliter (mcg/ml) | Standard Deviation 0.716 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: TEZ | 1.60 micrograms per milliliter (mcg/ml) | Standard Deviation 0.951 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: TEZ-M1 | 7.06 micrograms per milliliter (mcg/ml) | Standard Deviation 2.37 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: ELX | 2.48 micrograms per milliliter (mcg/ml) | Standard Deviation 1.65 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: ELX | 2.91 micrograms per milliliter (mcg/ml) | Standard Deviation 1.38 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: ELX | 3.13 micrograms per milliliter (mcg/ml) | Standard Deviation 1.9 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: ELX-M23 | 1.48 micrograms per milliliter (mcg/ml) | Standard Deviation 1.27 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: ELX-M23 | 1.73 micrograms per milliliter (mcg/ml) | Standard Deviation 0.828 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: TEZ | 1.73 micrograms per milliliter (mcg/ml) | Standard Deviation 0.666 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: TEZ | 1.52 micrograms per milliliter (mcg/ml) | Standard Deviation 0.701 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: TEZ-M1 | 7.07 micrograms per milliliter (mcg/ml) | Standard Deviation 1.08 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: TEZ-M1 | 6.80 micrograms per milliliter (mcg/ml) | Standard Deviation 1.64 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: IVA | 0.549 micrograms per milliliter (mcg/ml) | Standard Deviation 0.373 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: IVA | 0.535 micrograms per milliliter (mcg/ml) | Standard Deviation 0.402 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: IVA | 0.383 micrograms per milliliter (mcg/ml) | Standard Deviation 0.203 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: IVA | 0.483 micrograms per milliliter (mcg/ml) | Standard Deviation 0.347 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: IVA-M1 | 1.47 micrograms per milliliter (mcg/ml) | Standard Deviation 0.969 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: IVA-M1 | 1.64 micrograms per milliliter (mcg/ml) | Standard Deviation 1.29 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: IVA-M1 | 1.19 micrograms per milliliter (mcg/ml) | Standard Deviation 0.602 |
| Part A: ELX/TEZ/IVA | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: IVA-M1 | 1.24 micrograms per milliliter (mcg/ml) | Standard Deviation 0.673 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: IVA | 0.594 micrograms per milliliter (mcg/ml) | Standard Deviation 0.405 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: ELX | 3.49 micrograms per milliliter (mcg/ml) | Standard Deviation 2.22 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: TEZ | 2.14 micrograms per milliliter (mcg/ml) | Standard Deviation 1.72 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: TEZ | 1.76 micrograms per milliliter (mcg/ml) | Standard Deviation 1.1 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: ELX-M23 | 2.33 micrograms per milliliter (mcg/ml) | Standard Deviation 1.87 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: IVA-M1 | 1.67 micrograms per milliliter (mcg/ml) | Standard Deviation 0.961 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: TEZ | 1.80 micrograms per milliliter (mcg/ml) | Standard Deviation 1.42 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: TEZ | 1.79 micrograms per milliliter (mcg/ml) | Standard Deviation 0.947 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: IVA | 0.530 micrograms per milliliter (mcg/ml) | Standard Deviation 0.474 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: TEZ-M1 | 7.09 micrograms per milliliter (mcg/ml) | Standard Deviation 2.18 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: TEZ-M1 | 7.07 micrograms per milliliter (mcg/ml) | Standard Deviation 2.11 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: TEZ-M1 | 7.18 micrograms per milliliter (mcg/ml) | Standard Deviation 2.38 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: IVA-M1 | 1.45 micrograms per milliliter (mcg/ml) | Standard Deviation 0.907 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: IVA-M1 | 1.51 micrograms per milliliter (mcg/ml) | Standard Deviation 0.911 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: TEZ-M1 | 6.95 micrograms per milliliter (mcg/ml) | Standard Deviation 2.77 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: ELX | 3.87 micrograms per milliliter (mcg/ml) | Standard Deviation 2.75 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: IVA | 0.580 micrograms per milliliter (mcg/ml) | Standard Deviation 0.511 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: ELX | 3.56 micrograms per milliliter (mcg/ml) | Standard Deviation 2.19 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: ELX | 3.18 micrograms per milliliter (mcg/ml) | Standard Deviation 2.19 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: ELX-M23 | 2.22 micrograms per milliliter (mcg/ml) | Standard Deviation 1.66 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Day 15: IVA | 0.661 micrograms per milliliter (mcg/ml) | Standard Deviation 0.552 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 12: ELX-M23 | 2.17 micrograms per milliliter (mcg/ml) | Standard Deviation 1.69 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 4: IVA-M1 | 1.52 micrograms per milliliter (mcg/ml) | Standard Deviation 0.737 |
| Part B: ELX/TEZ/IVA (≥14 kg) | Part B: Observed Pre-dose Plasma Concentration (Ctrough) of ELX,TEZ,IVA and Relevant Metabolites | Week 16: ELX-M23 | 1.94 micrograms per milliliter (mcg/ml) | Standard Deviation 1.58 |