Studying Different Formulations of SR13668 in Healthy Volunteers

NCT00896207 | Completed Phase 1

• 6 other identifiers: NCI-2009-01106MAYO-MAY07-9-01CDR0000638390MAY-07-9-01MAY07-9-01P30CA015083
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized early phase I trial is studying different formulations of SR13668 in healthy volunteers. Giving SR13668 may help doctors learn more about how SR13668 is used by the body. It is not yet known which formulation of SR13668 is most effectively used by the body.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (2)

• Food effect on the bioavailability of SR13668 after oral administration

  The first stage will be used to compare fed vs. fasted diet effect on the pharmacokinetics parameters under formulation 1.

  Up to 30 days after completion of study treatment

• Formulation effect on the bioavailability of SR13668 after oral administration

  The second stage will be used to determine the formulation effects on the pharmacokinetics parameters, all under either fed or fasted diet as determined by the first stage.

  Up to 30 days after completion of study treatment

Secondary Outcomes (4)

• Solubility and stability of Akt inhibitor SR13668 in oral formulations selected for exploratory pharmacokinetics studies

  Up to 30 days after completion of study treatment

• Oral pharmacokinetics of a single low dose of Akt inhibitor SR13668

  Up to 30 days after completion of study treatment

• Metabolism of Akt inhibitor SR13668

  Up to 30 days after completion of study treatment

• Preliminary safety data for Akt inhibitor SR13668, graded according to NCI CTCAE version 3.0

  Up to 30 days after completion of study treatment

Study Arms (6)

Arm I

EXPERIMENTAL

Participants complete an overnight fast of ≥ 10 hours, eat a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800-1,000 calories) meal, and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.

Drug: Akt inhibitor SR13668

Arm II

EXPERIMENTAL

Participants complete an overnight fast of ≥ 10 hours and then receive a single dose of oral SR13668 in a PEG400/Labrasol® liquid formulation with 8 ounces of water. Participants may not eat for ≥ 4 hours after study drug administration.

Drug: Akt inhibitor SR13668

Arm III

EXPERIMENTAL

Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol® self-emulsifying solid dispersion capsule formulation.

Drug: Akt inhibitor SR13668

Arm IV

EXPERIMENTAL

Participants receive a single dose of oral Akt inhibitor SR13668 in a Solutol®/vitamin E TGPS self-emulsifying solid dispersion capsule formulation.

Drug: Akt inhibitor SR13668

Arm V

EXPERIMENTAL

Participants receive a single dose of oral Akt inhibitor SR13668 in a vitamin E TGPS self-emulsifying solid dispersion capsule formulation.

Drug: Akt inhibitor SR13668

Arm VI

EXPERIMENTAL

Participants receive a single dose of oral Akt inhibitor SR13668 in a Myrj 53 self-emulsifying solid dispersion capsule formulation.

Drug: Akt inhibitor SR13668

Interventions

Akt inhibitor SR13668 DRUG

Given orally as a single dose

Also known as: SRI13668

Arm I; Arm II; Arm III; Arm IV; Arm V; Arm VI

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer
• ECOG performance status 0
• Leukocyte count ≥ 3,000/mm\^3
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin normal
• Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
• ALT ≤ 1.5 times ULN
• Direct bilirubin ≤ 1.5 times ULN
• Sodium ≤ 1.5 times ULN
• Potassium ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 30 mL/min
• Fasting blood glucose normal
• Not pregnant or nursing
• Negative pregnancy test

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Paul Limburg

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 11, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 8, 2014

Record last verified: 2011-10

Locations

US (1)