Treatment of Chlamydia Infection Comparing WC2031 Tablets With Vibramycin

• Microbiological Cure and Clinical Cure of C. Trachomatis, Day 28, Clinically Evaluable Population, Percentage Participants Cured [ Time Frame: End of Study (Day 28) ] [ Designated as safety issue: No ]
  Microbiological cure (defined as a negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification Test and clinical cure (for males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritus and urethral discharge, and resolution of exam finding of urethral discharge; for females resolution of exam finding of endocervical discharge) at Day 28
• Microbiological Cure C. Trachomatis and M. Genitalium, M. Genitalium Coinfected Population, Day 28, Percentage Participants Cured [ Time Frame: End of Study (Day 28) ] [ Designated as safety issue: No ]
  Percentage Subjects Cured of both M. genitalium and C. trachomatis M. genitalium co-infected population: microbiological cure for both at Day 28, defined as negative PCR (polymerase chain reaction) for M. genitalium and negative GP AC2 NAAT (Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) for C. trachomatis at Day 28
• Microbiological Cure C. Trachomatis, N. Gonorrhoea Negative Population, Day 28, Percentage Participants Cured [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  Percentage Participants cured in N. gonorrhoea Negative Population: cured defined as both microbiological cure (negative result for urogenital C. trachomatis, determined by GP AC2 NAAT/Gen-Probe Aptima Combo 2 Nucleic Acid Amplification test) and clinical cure (males defined as resolution of baseline signs/symptoms of dysuria, urethral pruritis and urethral discharge, and resolution of exam finding of urethral discharge; females - resolution of exam finding of endocervical discharge) at Day 28

Evaluate the clinical efficacy and safety of WC2031 200 mg tablets taken orally once a day for 7 days versus Vibramycin (doxycycline) 100 mg capsules taken orally twice a day for 7 days, for the treatment of uncomplicated urogenital Chlamydia trachomatis infection. Primary efficacy endpoint is microbiological cure at Day 28. Safety assessments are adverse events, changes in vital signs and laboratory test results.

• Drug: Doxycyline Hyclate tablet
  200 mg tablet, once daily for 7 days
  Other Name: WC2031
• Drug: Vibramycin (doxycyline hyclate) capsule
  100 mg capsule, twice daily for 7 days, over-encapsulated
  Other Name: doxycycline

• Experimental: Doxycycline Hyclate 200 mg tablet
  Once daily
  Intervention: Drug: Doxycyline Hyclate tablet
• Active Comparator: Vibramycin 100 mg capsule
  Twice daily
  Intervention: Drug: Vibramycin (doxycyline hyclate) capsule

Inclusion Criteria:

• 19-45 years of age, male or female
• presumed diagnosis of urogenital C. trachomatis infection
• use condoms during sexual activity during study (enrollment thru day 28)

Exclusion Criteria:

• Clinical diagnosis pelvic inflammatory disease or epididymitis at baseline
• Diagnosis of N. gonorrhoea
• HIV infection
• Active Hepatitis B or C infection
• Prior hysterectomy (partial or total)
• Treatment with antimicrobial therapy with known activity against urogenital C. trachomatis within 28 days of enrollment