A study to compare a pediatric tablet or suspension of elvitegravir verses the adult 150 mg tablet in healthy adult volunteers

• Register: EUCTR
• Last refreshed on: 23 February 2015
• Main ID: EUCTR2015-000725-37-Outside-EU/EEA
• Date of registration: 18/02/2015
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences, Inc.
• Public title: A study to compare a pediatric tablet or suspension of elvitegravir verses the adult 150 mg tablet in healthy adult volunteers
• Scientific title: A Phase 1 Study to Evaluate the Bioavailability of Boosted Age-Appropriate Pediatric Elvitegravir (EVG) Tablet or Suspension Formulation Compared with Adult EVG 150 mg Tablets in Healthy Adult Volunteers
• Target sample size: 78
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000725-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: The comparator is EVG Adult formulation against EVG pediatric formulation Number of treatment arms in the trial: 3

Countries of recruitment

United States

Contacts

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences International Ltd

• Name: Clinical Trials Mailbox
• Affiliation: Gilead Sciences International Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria (as applicable) to be eligible for participation in this study.

1. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
2. Must be between 18 and 45 years of age, inclusive.
3. Must be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug.
4. Must have a calculated body mass index (BMI) from 19 = BMI = 30 kg/m2 at study screening.
5. Must be HIV-1 antibody negative.
6. Must be hepatitis B (HBV) surface antigen negative.
7. Must be hepatitis C (HCV) antibody negative.
8. Have an estimated creatinine clearance (CLCr) = 90 mL/min (using the Cockcroft-Gault method)
9. Females of childbearing potential (as defined in Section 7.9.1) must have a negative serum pregnancy test.
10. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from 3 weeks prior to baseline (Day -1) throughout the duration of study treatment and for 30 days following the last dose of study drug.
11. Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study dosing.
12. Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product.
13. Male subjects must refrain from sperm donation from Day -1 through completion of the study and continuing for at least 30 days from the date of last dose of study drug.
14. Subjects must refrain from blood donation from Day -1 through completion of the study and continuing for at least 30 days from date of last dose of study drug.
15. Must, in the opinion of the Investigator, be in good health based upon medical history, physical examination (including vital signs), and screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall within the normal range of the local laboratory’s reference ranges unless the results have been determined by the Investigator to have no clinical significance.
16. Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant by the Investigator in consultation with the Sponsor. Subjects must have PR between 120 – 210 msec, and QTcF of <450 for males and <470 for females.
17. Must be willing and able to comply with all study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects who meet any of the following exclusion criteria (as applicable) are not to be enrolled in this study.
1. Pregnant or lactating subjects.
2. Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
3. Have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
4. Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
5. Have poor venous access and are unable to donate blood.
6. Have donated blood within 56 days of study dosing.
7. Have donated plasma within 7 days of study dosing.
8. Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
9. Have history of significant drug sensitivity or drug allergy. disorders, active infection, or malignancy that are clinically significant or requiring treatment.
10. Known hypersensitivity to the study drugs, the metabolites or formulation excipients
11. Have been treated with systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies).
12. Have a history or family history of Long QT Syndrome, Wolfe-Parkinson-White Syndrome, or have a family history of sudden cardiac death or unexplained death in an otherwise healthy individual between the ages of 1 and 40 years.
13. History of syncope, palpitations, or unexplained dizziness.
14. Have an implanted defibrillator or pacemaker.
15. Have a history of liver disease, including Gilbert’s Disease.
16. Are unable to comply with study requirements.
17. Believed, by the study Investigator, to be inappropriate for study participation for any reason.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus (HIV-1) Infection
MedDRA version: 17.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: elvitegravir
Product Code: GS-9137 (EVG)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: ELVITEGRAVIR
CAS Number: 697761-98-1
Current Sponsor code: GS-9137 (EVG)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: Elvitegravir
Product Code: GS-9137 (EVG)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Elvitegravir
CAS Number: 697761-98-1
Other descriptive name: ELVITEGRAVIR
Concentration unit: millilitre(s)/gram
Concentration type: equal
Concentration number: 50-

Product Name: Elvitegravir suspension formula
Product Code: GS-9137 (EVG)
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: ELVITEGRAVIR
CAS Number: 697761-98-1
Other descriptive name: ELVITEGRAVIR
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 5-

Trade Name: Ritonavir (Norvir) Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: The primary objective of this study is to evaluate the relative bioavailability of two age-appropriate pediatric formulations (tablet and suspension formulation) of EVG co-administered with ritonavir in healthy adult subjects

Timepoint(s) of evaluation of this end point: At screening, baseline (Day -1), and at various time points during the study

Primary end point(s): The primary endpoints were the PK parameters AUClast, AUCinf, and Cmax for EVG.

Secondary Objective: The secondary objective of this study is to evaluate the safety of two age-appropriate pediatric formulations (tablet and suspension formulation) of EVG co-administered with ritonavir in healthy adult subjects

Secondary Outcome(s)

Secondary end point(s): The secondary endpoints were %AUCexp, Tmax, Clast, Tlast, ?z, and t1/2 of EVG in Cohort 1 and Cohort 2, AUClast, AUCinf, and Cmax of RTV in Cohort 1 and Cohort 2, AUCtau, Ctau, and Cmax of EVG and RTV in Cohort 3, and the incidences of AEs and laboratory abnormalities.

Timepoint(s) of evaluation of this end point: At screening, baseline (Day -1), and at various time points during the study

Secondary ID(s)

GS-US-183-0149

Source(s) of Monetary Support

Gilead Sciences, Inc.