A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018823
• Other study ID #: 8835-037
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2009
• Est. completion date: March 18, 2010

Study information

• Verified date: May 2020
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.

Description:

To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 18, 2010
• Est. primary completion date: March 18, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL

Related Conditions & MeSH terms

• Healthy Volunteer
• Overweight

Intervention

Drug:
• Ertugliflozin
Ertugliflozin oral dosing 1 mg, 5 mg, 25 mg, or 100 mg solutions/suspensions administered once daily for 14 days immediately after breakfast
• Placebo to Ertugliflozin
Placebo oral dosing solutions/suspensions administered once daily for 14 days immediately after breakfast

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Pfizer

References & Publications (1)

Fediuk DJ, Nucci G, Dawra VK, Cutler DL, Amin NB, Terra SG, Boyd RA, Krishna R, Sahasrabudhe V. Overview of the Clinical Pharmacology of Ertugliflozin, a Novel Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. Clin Pharmacokinet. 2020 Apr 27. doi: 10.1007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing an Adverse Event (AE)		Up to 28 days postdose (Up to 42 days)
Primary	Number of Participants Discontinuing Study Drug Due to an AE		Up to 14 days
Primary	Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin		Up to 17 days
Primary	Maximum plasma concentration (Cmax) of ertugliflozin		Up to 17 days
Primary	Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin		Up to 17 days
Primary	Ertugliflozin half life (t1/2)		Up to 17 Days
Primary	Apparent clearance (CL/F) after a single dose of ertugliflozin		Up to 17 days
Primary	Apparent volume of distribution (Vz/F)		Up to 17 days
Primary	Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs])		Up to 17 days
Primary	Change from baseline in 24-hour weighted mean glucose		Baseline and Day 14
Primary	Change from baseline in 24-hour urinary glucose excretion		Baseline and Day 14
Primary	Change from baseline in 24-hour plasma C-peptide		Baseline and Day 14
Primary	Inhibition of glucose reabsorption		Baseline and Day 14
Primary	Change from baseline in body weight		Baseline and Day 14
Primary	Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone		Up to 17 days
Primary	Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone		Up to 17 days
Primary	Trough concentration of serum intact parathyroid hormone (Ctrough)		Up to 17 days