NCT03700658

A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous (SC) Administration of TV-46046

A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the local tolerability associated with the SC administration of TV-46046, and inform next steps of the TV-46046 development program.

Detailed description

Eligible participants will be enrolled and receive 1 of each of the 4 SC study injections in each abdominal quadrant approximately 1 hour apart: 120 milligrams (mg)/0.3 milliliter (mL) of TV-46046, 60 mg/0.3 mL of 1:1 saline diluted TV-46046, 0.3 mL of TV-46046 Placebo and 104 mg/0.65 mL Depo-subQ 104 per the assigned sequence.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	TV-46046	TV-46046 will be administered per dose and schedule specified in the arm.
DRUG	Depo-subQ 104	Depo-subQ 104 will be administered per dose and schedule specified in the arm.
DRUG	TV-46046 Placebo	TV-46046 Placebo will be administered per schedule specified in the arm.

Timeline

• Start date: 2019-01-15
• Primary completion: 2020-10-02
• Completion: 2020-10-02
• First posted: 2018-10-09
• Last updated: 2022-01-26
• Results posted: 2022-01-26

Locations

1 site across 1 country: Dominican Republic

Regulatory

• FDA-regulated drug study