Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

• Sponsor: Biogen (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01238679
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 7
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-04958242; Drug: Placebo	Phase 1

Detailed Description

A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I, Randomized, Subject and Investigator-Blind, Sponsor Open, Multiple Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers
• Actual Study Start Date: Nov 24, 2010
• Actual Primary Completion Date: May 3, 2011
• Actual Study Completion Date: May 3, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Participants received an oral solution of 0.03 milligrams (mg) of PF-04958242, every 12 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 2 Participants received an oral solution of 0.05 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 3 Participants received an oral solution of 0.10 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 4 Participants received an oral solution of 0.15 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 5 Participants received an oral solution of 0.20 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 6 Participants received an oral solution of 0.25 mg of PF-04958242, every 24 hours for 14 days.	Drug: PF-04958242; Administered as specified in the treatment arm
Placebo Comparator: Matching Placebo Participants received an oral solution of matching placebo, every 12 or 24 hours for 14 days.	Drug: Placebo; Administered as specified in the treatment arm

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Adverse Events and Serious Adverse Events [Baseline up to Day 23]

   An adverse event is any untoward medical occurrence in a clinical investigation subject administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.

2. Maximum Plasma Drug Concentration (Cmax) for Single Dose [Day 1 and at multiple time points up to Day 17]

3. Time to Reach Maximum Plasma Concentration (Tmax) for Single Dose [Day 1 and at multiple time points up to Day 17]

4. Area Under the Concentration Time-curve During a Dosage Interval (AUCτ) for Single Dose [Day 1 and at multiple time points up to Day 17]

5. Maximum Observed Plasma Concentration (Cmax) for Steady State [Day 1 and at multiple time points up to Day 17]

6. Area Under the Plasma Drug Concentration-Time Curve During a Dosage Interval (AUCτ) for Steady State [Day 1 and at multiple time points up to Day 17]

7. Apparent Total Clearance of the Drug from Plasma (CL/F) for Steady State [Day 1 and at multiple time points up to Day 17]

8. Apparent Volume of Distribution During Terminal Phase (Vz/F) for Steady State [Day 1 and at multiple time points up to Day 17]

9. Elimination Half-Life (t1/2) for Steady State [Day 1 and at multiple time points up to Day 17]

10. Accumulation Ratio (AUC(τ,ss)/AUC(τ,sd)) for Steady State [Day 1 and at multiple time points up to Day 17]

11. Percent of Dose Eliminated in Urine Unchanged (Ae%) [Day 14]

12. Amount of PF-04958242 Eliminated in Urine Unchanged (Ae) [Day 14]

13. Renal Clearance (CLr) [Day 14]

14. Time to Reach Maximum Plasma Concentration (Tmax) for Steady State [Day 1 and at multiple time points up to Day 17]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

• Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);

• Total body weight >50 kilograms (kg) (110 pounds [lbs]);

Key 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);

• Positive urine drug screen;

• Pregnant or nursing females, and females of child bearing potential;

• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Singapore		Singapore	188770

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01238679
• Other Study ID Numbers: B1701002
• First Posted: Nov 10, 2010
• Last Update Posted: Dec 24, 2019
• Last Verified: Dec 1, 2019

Study Results

No Results Posted as of Dec 24, 2019