Effects of Food on the Pharmacokinetics of Tesetaxel 10 mg Capsules

NCT01170975 | Completed Phase 1

• 1 other identifier: TOPK103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects of food (a high-fat meal) on the pharmacokinetics of tesetaxel.

Conditions

Solid Tumors

Keywords

Advanced solid tumors

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters

  Pharmacokinetic parameters include the area under the blood concentration-time curve (AUC0-inf, AUC0-t), concentration 24 h post dose (C24), maximum blood concentration (Cmax), time to maximum blood concentration (Tmax), terminal half-life (t½), and oral clearance (CL/F)

  Predose and postdosing up to 36 days after administration of each dose

Secondary Outcomes (1)

• Safety and tolerability

  From screening through 36 days after administration of the final dose

Study Arms (2)

Treatment sequence 1

OTHER

Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state

Drug: Tesetaxel 10 mg with and then without food

Treatment sequence 2

OTHER

Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state

Drug: Tesetaxel 10 mg without and then with food

Interventions

Tesetaxel 10 mg with and then without food DRUG

Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state

Treatment sequence 1

Tesetaxel 10 mg without and then with food DRUG

Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state

Treatment sequence 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 75 years of age.
• Histologically or cytologically confirmed advanced solid tumor malignancy.
• Negative serum pregnancy test within 7 days prior to the first dose of study drug in women of childbearing potential.
• Agreement to use a highly effective form of contraception throughout the treatment phase of the study in women of childbearing potential and sexually active men.
• Body weight ≥ 50 kg for women and men and BMI within the range of 19 to 35 kg/m2 inclusive.
• lead ECG without any clinically significant abnormality as judged by the Investigator.
• Able to swallow oral medication.
• Adequate organ system function.

You may not qualify if:

• A positive pre-study hepatitis B surface antigen.
• Symptomatic or acute hepatic or biliary abnormalities.
• Clinically significant gastrointestinal abnormalities that increase the risk for perforation.
• Presence of uncontrolled infection.
• Positive pre-study drug/alcohol screen.
• Treatment with an investigational agent within the following time periods prior to the first dose of study drug: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longest).
• Current treatment with any cancer therapy that is causing significant gastrointestinal side effects, including but not limited to, nausea, vomiting, and diarrhea.
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with a subject's safety, obtaining informed consent, or compliance with the study.
• Pregnancy or lactation.
• Hypoalbuminemia (serum albumin \<3.0 g/dL) at screening.
• Consumption of red wine, seville oranges, grapefruit or grapefruit juice, and/or pummelos, exotic citrus fruits, or grapefruit hybrids within 14 days prior to the first dose of study drug.

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

DaVita Clinical Researh

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Interventions

tesetaxel; Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Harry W Alcorn, PharmD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 28, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

US (1)