Will Be Recruiting
Sponsor ID
20220137

Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation

Sponsor ID
20220137
Clinicaltrials.gov ID
N/A
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.

Additional Study Details

Phase
Phase 1
Product
AMG 407
Type
Interventional
Masking
None (Open Label)
Enrollment
114
Additional Study Details

Protocol Summary

Primary Outcome Measures

Area Under the Plasma Concentration-time Curve (AUC) from Time Zero extrapolated to Infinity (AUCinf) of Apremilast.

Timeframe: Pre-dose on Day 1 through Day 4 of each treatment period

Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Apremilast

Timeframe: Pre-dose on Day 1 through Day 4 of each treatment period

Maximum Observed Plasma Concentration (Cmax) of Apremilast.

Timeframe: Pre-dose on Day 1 through Day 4 of each treatment period

Secondary Outcome Measures

Number of participants who experience treatment-emergent adverse events .

Timeframe: Baseline through end of study (up to approximately 12 days)

Number of participants who experience Serious adverse events

Timeframe: From Screening (Day-28) through end of study (up to approximately 40 days)

Locations

No locations found.