An Open-label, Non-randomised, Fixed-sequence, Two Period, Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 (Survodutide) on the Single Dose Pharmacokinetics of Bupropion, Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity

Registration

Registration

NCT06564441

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

34

Start

2024-10-01

Primary completion

2025-12-16

Lead sponsor

Boehringer Ingelheim

Conditions

Overweight; Obesity

Interventions

COMBINATION_PRODUCT:Survodutide; DRUG:Bupropion; DRUG:Caffeine; DRUG:Midazolam

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

REGISTRY:2024-512332-29-00; REGISTRY:U1111-1307-0132

Registered primary outcomes

• Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) [Up to week 32]
• Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) [Up to week 32]
• Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) [Up to week 32]
• Maximum measured concentration of bupropion in plasma (Cmax) [Up to week 32]
• Maximum measured concentration of caffeine in plasma (Cmax) [Up to week 32]
• Maximum measured concentration of midazolam in plasma (Cmax) [Up to week 32]