Pharmacokinetics and Tolerability of Minodronic Acid and Food and Age Effects on the Pharmacokinetics

Osteoporosis Clinical Trial

Official title:

Pharmacokinetics and Tolerability of Minodronic Acid Tablets in Healthy Chinese Subjects and Food and Age Effects on the Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295436
• Other study ID #: WHXH-MINO
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2014
• Last updated: November 19, 2014
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy Chinese subjects. Additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.

Description:

This was a single-center, phase I study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. In Part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. In Part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. In Part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. In part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). Plasma samples were collected and plasma concentrations of minodronic acid were analyzed by LC-MS/MS. Tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects were included based on the following criteria:

• males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects

• body mass index between 19 and 24 kg/m2

• thorax radiography and ECG with no abnormalities

• normal blood pressure values

• heart rate

• laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis)

• negative test results for HIV and hepatitis B.

Exclusion Criteria:

• Subjects were excluded if they had a heart disease or disorder

• A hepatic, renal, respiratory, immune system, or nervous system disorder

• Any of the following conditions:

• pregnancy

• breast-feeding

• hypocalcemia

• prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study

• blood donation or participation in other clinical trials within 3 months before enrollment in the study

• alcohol or drug abuse

• smoking more than 10 a day

• clinically significant allergies to drugs or foods

• sitting blood pressure <80/50 mm Hg or >140/100 mm Hg

• A ventricular rate <60 beats/min or >100 beats/min at rest.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• minodronic acid
comparison of different doses, ages and medication conditions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	the maximum observed plasma concentration and	two months	No
Primary	AUC	the area under the concentration-time curve	two months	No
Secondary	adverse events		two months	Yes