A Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca

About this trial

The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy participants with suitable veins for cannulation or repeated venipuncture.

All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

Females of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.

Females of non-childbearing potential must be confirmed at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.

Disqualifiers

History of any clinically important disease or disorder.

History of acute pancreatitis.

History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Elecoglipron Reference Formulation Dose A

    Drug

    Elecoglipron tablets will be administered orally.

  • Elecoglipron Test formulation 1 Dose A

    Drug

    Elecoglipron tablets will be administered orally.

  • Elecoglipron Reference Formulation Dose B

    Drug

    Elecoglipron tablets will be administered orally.

  • Elecoglipron Test formulation 1 Dose B

    Drug

    Elecoglipron tablets will be administered orally.

  • Elecoglipron Test formulation 2 Dose A

    Drug

    Elecoglipron tablets will be administered orally.

  • Elecoglipron Test formulation 2 Dose B

    Drug

    Elecoglipron tablets will be administered orally.

Treatment groups

152 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort 1-Treatment Sequence AExperimental treatment 2 interventions
Group B: Cohort 1 - Treatment Sequence BExperimental treatment 2 interventions
Group C: Cohort 2 - Treatment Sequence CExperimental treatment 2 interventions
Group D: Cohort 2 - Treatment Sequence DExperimental treatment 2 interventions
Group E: Cohort 3 - Treatment Sequence EExperimental treatment 2 interventions
Group F: Cohort 3 - Treatment Sequence FExperimental treatment 2 interventions
Group G: Cohort 4 - Treatment Sequence GExperimental treatment 2 interventions
Group H: Cohort 4 - Treatment Sequence HExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Maximum observed drug concentration (Cmax)

To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

Time frame
At pre-defined intervals from Day 1 to Day 15
2

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

Time frame
At pre-defined intervals from Day 1 to Day 15
3

Area under concentration-time curve from time 0 to infinity (AUCinf)

To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

Time frame
At pre-defined intervals from Day 1 to Day 15
4

Time to reach maximum observed concentration (tmax)

To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.

Time frame
At pre-defined intervals from Day 1 to Day 15

Secondary outcomes

1

Number of participants with adverse events (AEs)

To assess the safety and tolerability of different formulations of elecoglipron following single oral administration in healthy participants.

Time frame
From screening (Day -28) up to follow-up visit (Day 18-Day 22)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.