Clinical trial NCT01395108: Clinical Study on Oral Nemonoxacin Malate Capsules
Official title: Phase I Clinical Study on Oral Nemonoxacin Malate Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: TaiGen Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-07-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of nemonoxacin in healthy Chinese volunteers.

Detailed description: Single dose study: evaluate safety and tolerability of oral nemonoxacin 125 mg, 250mg, 500mg, 750mg, and 1000mg.

Multiple dose study: evaluate PK profile of oral doses of 500mg or 750mg nemo after consecutive 10 days.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females, aged between 18 and 45 during screening
* Male volunteers who are capable of taking double-barrier contraception measures during the test (spermicide gel plus condom, for instance) until the end of the clinical study and do not cause their spouses to conceive within three months after the last administration of the medication; if the subjects are females, they shall not become pregnant during the test and within three months after the study
* No use of tobacco or nicotine product within 3 months prior to this study
* BMI 19-25
* Willing to abstain from coffee and any caffeine drink during the study
* Voluntarily sign the informed consent

Exclusion Criteria:

* History of diabetes, or cardiovascular, hepatic or renal disease
* Active digestive disease (e.g. diarrhea)
* Central nervous disease or psychiatric disorders
* Had surgery or trauma within 6 months prior to this study
* Alcohol or drug abuse
* HIV, HBV or HCV positive
* Used any prescribed drug (including traditional chinese medicine) within 14 days prior to the study
* Donated 400ml of blood or plasma within 3 months prior to this study
* Have an abnormal laboratory examination value that exceeds the normal range by 10%
* Drug allergies
* Have cardiac disorders or have a family history of cardiac disorders
* Have abnormal 12-lead ECG during screening
* Pregnant or lactating
* Participated in any study within 3 months prior to this study

Primary outcomes:
measure: Maximum tolerated single oral dose of nemonoxacin in healthy Chinese volunteers
timeFrame: 7 days
measure: Pharmacokinetic profile of single oral dose of nemonoxacin in healthy Chinese volunteers
timeFrame: 7 days
measure: Pharmacokinetic profile of repeated oral doses of nemonoxacin in healthy Chinese volunteers
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Institute of Antibiotics, Huashan Hospital, Fundan University
Study officials:
affiliation: Huashan Hospital, Fundan University
name: Yingyuan Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo B, Wu X, Zhang Y, Shi Y, Yu J, Cao G, Zhang J. Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses. Clin Drug Investig. 2012 Jul 1;32(7):475-86. doi: 10.2165/11632780-000000000-00000.