Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active Obesity Part B |
Other: Placebo
Placebo once daily for up to 42 days.
Drug: Clopidogrel
Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Other Names:
|
| Placebo Comparator: Placebo Obesity Part B |
Other: Placebo
Placebo once daily for up to 42 days.
Drug: Clopidogrel
Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
Other Names:
|
| Experimental: Active T2DM Parts A and C |
Drug: PF-07081532
Investigational Drug once daily for up to 42 days; multiple ascending dose design.
|
| Placebo Comparator: Placebo T2DM Parts A and C |
Drug: PF-07081532
Investigational Drug once daily for up to 42 days; multiple ascending dose design.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Treatment Emergent Treatment-Related Adverse Events [Baseline up to a minimum of 28 days after last administration of investigational product.]
- Number of Participants with Laboratory Abnormalities [From Baseline to 7-14 days following last dose administration.]
- Number of Participants with Clinically Significant Change from Baseline in Vital Signs [From Baseline to 7-14 days following last dose administration.]
- Number of Participants with Abnormal Electrocardiogram [From Baseline to 7-14 days following last dose administration.]
Secondary Outcome Measures
- AUC24: Area under the Curve from time zero to 24 hours post dose. [Part A: 0-24 hours post-dose on selected study days from day 1 to day 28. Parts B/C (if conducted): 0-24 hours post-dose on selected study days from day 1 to day 42.]
- Cmax: Maximum Observed Plasma Concentration [Part A: selected study days from day 1 to day 28. Parts B/C (if conducted): selected study days from day 1 to day 42.]
- Tmax: Time to Reach Maximum Observed Plasma Concentration [Part A: selected study days from day 1 to day 28. Parts B/C (if conducted): selected study days from day 1 to day 42.]
- t 1/2: Time measured for the plasma concentration to decrease by one-half. [Part A: Day 28 0-72 hours post-dose. Parts B/C (if conducted): also day 42 0-72 hours post-dose.]
- Ae24: Cumulative Amount of Drug Recovered Unchanged in Urine [Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs).]
Ae24 is the cumulative amount of drug recovered unchanged in urine over 24 hours. Cumulative amount is calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020) where 1.020 g/mL is the approximate specific gravity of urine.
- Ae24%: Percentage of dose recovered in urine as unchanged drug [Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs).]
Calculated as 100 x Ae24 divided by the dose administered
- CLr: Renal Clearance [Part A: Day 28 (0-24 hrs). Part C (if conducted): Day 42 (0-24 hrs).]
Renal clearance is calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae24) divided by area under the plasma concentration time curve from time zero to end of dosing interval (AUC24), where dosing interval is 24 hours.
Eligibility Criteria
Criteria
Key Inclusion Criteria for participants enrolling with T2DM:
-
Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
-
HbA1c value between 7.0% and 10.5%, inclusive.
Key Exclusion Criterion for participants enrolling with T2DM:
-Type 1 Diabetes or secondary forms of diabetes.
Key Inclusion Criterion for participants enrolling with obesity:
-Obese (as indicated by screening BMI) non-diabetic adults.
Key Exclusion Criterion for participants enrolling with obesity:
--Type 1 or Type 2 Diabetes or secondary forms of diabetes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
| 2 | Qps-Mra, Llc | South Miami | Florida | United States | 33143 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C3991002