Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: VX-509

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789126

VX08-509-002

Details and patient eligibility

About

Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects

Full description

Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.

Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.

A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
• Able to comply with study procedures
• Male subjects must agree to use 2 highly effective methods of contraception
• Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
• No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results

Exclusion criteria

• History of any significant illness
• Illness within 5 days before Day 1
• Regular treatment with any medications
• Any type of tobacco or nicotine use
• History of drug or alcohol abuse or addiction within 2 years before Screening visit
• Positive tuberculin skin test at Screening
• Female subjects who are lactating or planning to become pregnant during the study period or within 90 days of last dose of study drug