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Sequence 1 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older and overtly healthy
BMI16-32 kg/m2; and a total body weight >50 kg (110 lb).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 hr 24 and hr 36 and day 3 hr 48
Awards & highlights

Study Summary

This trial aims to understand how different forms of a medication called danuglipron are absorbed into the bloodstream in healthy adults.

Who is the study for?
This trial is for healthy adults over 18 years old with a Body Mass Index (BMI) between 16 and 32, and who weigh more than 110 pounds. It's not suitable for those outside these weight criteria or those with health conditions that could affect the study.Check my eligibility
What is being tested?
The study is testing how different forms of a medication called danuglipron are absorbed into the bloodstream. Participants will receive one of four formulations labeled as B, D, A, or C to compare their effects.See study design
What are the potential side effects?
Since this trial involves healthy volunteers and the description doesn't specify side effects, they may range from none to mild reactions at the site of administration or general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older and in good health.
Select...
My BMI is between 16 and 32, and I weigh more than 110 pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 hr 24 and hr 36 and day 3 hr 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 hour (hr) 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, day 2 hr 24 and hr 36 and day 3 hr 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Curve from Time Zero to Extrapolated infinite Time (AUCinf) for Formulations A, B, C and D, in a fasted state
Maximum observed plasma concentration for Formulations A, B, C and D, in a fasted state
Secondary outcome measures
Area Under the Plasma Curve from Time Zero to Extrapolated infinite Time (AUCinf) for MR formulation B in the fed (Test), compared to the fasted state
Maximum observed plasma concentration for MR formulation B in the fed (Test), compared to the fasted state
Number of Participants with Clinically Significant Abnormal Laboratory Values
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sequence 4Experimental Treatment4 Interventions
Period 1: 80 mg dose of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet), Period 2: 80 mg dose of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 3:80 mg dose of danuglipron MR, fasted state (Formulation B, 1×80 mg tablet) Period 4: 80 mg dose of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 5: 80 mg dose of danuglipron MR, fed consition (Formulation B, 1×80 mg tablet)
Group II: Sequence 3Experimental Treatment4 Interventions
Period 1: 80 mg dose of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 2: 80 mg dose of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 3: 80 mg dose of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet) Period 4: 80 mg dose of danuglipron MR, fasted state (Formulation B, 1×80 mg tablet) Period 5: 80 mg dose of danuglipron MR, fed condition (Formulation B, 1×80 mg tablet)
Group III: Sequence 2Experimental Treatment4 Interventions
Period 1: 80 mg dose of danuglipron MR, fasted state (Formulation B, 1×80 mg tablet), Period 2: 80 mg tablet of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet), Period 3: 80 mg tablet of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 4: 80 mg tablet of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 5: 80 mg dose of danuglipron MR, fed condition (Formulation B, 1×80 mg tablet)
Group IV: Sequence 1Experimental Treatment4 Interventions
Period 1: 80 mg dose of danuglipron IR, fasted state (Formulation A, 2×40 mg tablets) Period 2: 80 mg dose of danuglipron MR, fasted state(Formulation B, 1×80 mg tablet) Period 3: 80 mg dose of danuglipron MR, fasted state (Formulation C, 1×80 mg tablet) Period 4: 80 mg of danuglipron MR, fasted state (Formulation D, 1×80 mg tablet) Period 5: 80 mg dose of danuglipron MR, fed conditions (Formulation B, 1×80 mg tablet)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Formulation A
2008
Completed Phase 2
~1350
Formulation C
2007
Completed Phase 1
~110
Formulation B
2008
Completed Phase 2
~1350
Formulation D
2007
Completed Phase 1
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,986 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,201 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently available to prospective participants?

"Indeed, as noted on clinicaltrials.gov, this trial is actively seeking eligible participants. The initial posting of the trial was made on November 27th, 2023 and it received its most recent update on December 18th, 2023."

Answered by AI

Has Sequence 2 received approval from the FDA for its use in medical treatment?

"Based on the assessment by our team at Power, Sequence 2 is assigned a safety rating of 1. This is because it is currently in Phase 1, where there exists limited data supporting both its safety and efficacy."

Answered by AI

What is the uppermost limit for participant enrollment in this research endeavor?

"Indeed, the information on clinicaltrials.gov indicates that this research is currently in need of participants. The trial was initially posted on November 27th, 2023 and most recently updated on December 18th, 2023. This study aims to recruit a total of 20 individuals from a single designated site."

Answered by AI

Who else is applying?

What site did they apply to?
Anaheim Clinical Trials, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults
2023. "Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153758.
~0 spots leftby May 2024
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